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64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05407311
Acronym
SABRE
Enrollment
53
Registered
2022-06-07
Start date
2022-09-19
Completion date
2024-05-13
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biochemical Recurrence of Malignant Neoplasm of Prostate

Brief summary

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with prostate-specific membrane antigen (PSMA)-negative biochemical recurrence of prostate cancer following definitive therapy.

Detailed description

Participants with biochemical evidence of recurrence of prostate cancer (PC) were evaluated with 64Cu-SAR-BBN PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later (e.g., histopathology/biopsy, conventional imaging, prostate specific antigen \[PSA\] reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy). Three independent, central readers blinded to the participant number, the time of the PET/CT scan, and the results of the conventional methodologies, assessed the 64Cu-SAR-BBN PET/CT. Three separate independent readers assessed the results of the conventional methodologies.

Interventions

DRUG64Cu-SAR-BBN

64Cu-SAR-BBN

Sponsors

Clarity Pharmaceuticals Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. At least 18 years of age. 2. Signed informed consent. 3. Life expectancy ≥ 12 weeks as determined by the Investigator. 4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy. 5. Suspected recurrence of PC based on rising PSA after definitive therapy on the basis of: 1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or 2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition). 6. Negative or equivocal findings for PC on (1) approved PSMA PET and (2) anatomical imaging (CT and/or magnetic resonance imaging) and (3) if available, any other conventional imaging performed as part of routine standard of care imaging workup within 60 days prior to Day 0. 7. The Eastern Cooperative Oncology performance status 0-2. 8. Adequate recovery from acute toxic effects of any prior therapy. 9. Estimated Glomerular Filtration Rate of 30 mL/min or higher. 10. Adequate liver function. 11. For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

Exclusion criteria

1. Participants who received other investigational agents within 28 days prior to Day 0. 2. Participants administered any high energy (\>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0. 3. Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC. 4. Participants who are known to require prohibited treatment (e.g., initiation of androgen-deprivation therapy due to rapidly rising PSA) before the 64Cu-SAR-BBN PET/CT results can be verified via histopathology or follow-up imaging. 5. Known or expected hypersensitivity to 64Cu-SAR-BBN or any of its components. 6. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Design outcomes

Primary

MeasureTime frameDescription
Safety and TolerabilityUp to 7 days post injectionIncidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Participant-level Correct Detection Rate (CDR) - Day 0Day 0 (1-4 hours) post injectionThe percentage of true positive (TP) participants on the Day 0 scan out of all participants with a Day 0 scan.
Participant-level CDR - Day 1.Day 1 (24+/-6 Hours) post injectionThe percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.
Region-level Positive Predictive Value (PPV) - Day 0.Day 0 (1-4 hours) post injectionThe percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.
Region-level PPV - Day 1.Day 1 (24 +/- 6 hours) post injectionThe percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.

Secondary

MeasureTime frameDescription
Biodistribution of 64Cu-SAR-BBN - SUVr - Day 1Day 1 (24 +/- 6 hours) post injectionSUVr: SUVmax of the lesion divided by the SUVmean of gluteus background.
Participant-level PPVDay 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injectionPercentage of TP participants out of all positive participants, derived separately for each timepoint and reader.
Participant-level Detection Rate (DR)Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injectionPercentage of participants with a positive 64Cu-SAR-BBN PET/CT scan out of all participants with a 64Cu-SAR-BBN PET/CT scan for each timepoint and reader.
Participant-level False Positive Rate (FPR)Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injectionPercentage of false positive (FP) participants out of all participants with a positive scan, derived separately for each timepoint and reader.
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0Day 0 (1-4 hours) post injectionThe mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue, bone.
Participant-level Discrepant PET Negativity RateDay 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injectionPercentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.
Participant-level True Negative Rate (TNR)Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injectionPercentage of true negative (TN) participants on the Day 0 or Day 1 scan out of all participants with a negative Day 0 or Day 1 scan.
Region-level TNRDay 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injectionPercentage of TN regions on the Day 0 or Day 1 scan out of all negative regions on the Day 0 or Day 1 scan.
Region-level FPRDay 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injectionPercentage of FP regions on the Day 0 or Day 1 scan out of all positive regions, derived separately for each timepoint and reader.
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1Day 1 (24 +/- 6 hours) post injectionThe SUVmean in lesions, visceral soft tissue, bone.
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0Day 0 (1-4 hours) post injectionThe max Standardized Uptake Value (SUVmax) in lesions, visceral soft tissue and bone.
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1Day 1 (24 +/- 6 hours) post injectionThe SUVmax in lesions, visceral soft tissue and bone.
Biodistribution of 64Cu-SAR-BBN - SUVr - Day 0Day 0 (1-4 hours) post injectionStandardized Uptake Value Lesion to Background ratio (SUVr): SUVmax of the lesion divided by the SUVmean of gluteus background.

Countries

United States

Participant flow

Recruitment details

Dates of recruitment period: 19 Sep 2022 to 14 Nov 2023

Participants by arm

ArmCount
64Cu-SAR-BBN
Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection.
53
Total53

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyNon-compliance1
Overall StudyPhysician Decision1
Overall StudyProtocol Violation3
Overall StudyWithdrawal by Subject5

Baseline characteristics

Characteristic64Cu-SAR-BBN
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
41 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
Baseline Prostate Specific Antigen (PSA)3.3932 ng/mL
STANDARD_DEVIATION 6.1338
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
5 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
48 Participants
Region of Enrollment
United States
53 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
53 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 53
other
Total, other adverse events
3 / 53
serious
Total, serious adverse events
0 / 53

Outcome results

Primary

Participant-level CDR - Day 1.

The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.

Time frame: Day 1 (24+/-6 Hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at Day 1.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNParticipant-level CDR - Day 1.Reader 210.6 percentage of participants
64Cu-SAR-BBNParticipant-level CDR - Day 1.Reader 14.3 percentage of participants
64Cu-SAR-BBNParticipant-level CDR - Day 1.Reader 314.9 percentage of participants
Primary

Participant-level Correct Detection Rate (CDR) - Day 0

The percentage of true positive (TP) participants on the Day 0 scan out of all participants with a Day 0 scan.

Time frame: Day 0 (1-4 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at Day 0.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNParticipant-level Correct Detection Rate (CDR) - Day 0Reader 114.9 percentage of participants
64Cu-SAR-BBNParticipant-level Correct Detection Rate (CDR) - Day 0Reader 214.9 percentage of participants
64Cu-SAR-BBNParticipant-level Correct Detection Rate (CDR) - Day 0Reader 314.9 percentage of participants
Primary

Region-level Positive Predictive Value (PPV) - Day 0.

The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.

Time frame: Day 0 (1-4 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at Day 0.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNRegion-level Positive Predictive Value (PPV) - Day 0.Reader 147.1 percentage of regions
64Cu-SAR-BBNRegion-level Positive Predictive Value (PPV) - Day 0.Reader 222.6 percentage of regions
64Cu-SAR-BBNRegion-level Positive Predictive Value (PPV) - Day 0.Reader 333.3 percentage of regions
Primary

Region-level PPV - Day 1.

The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.

Time frame: Day 1 (24 +/- 6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at Day 1.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNRegion-level PPV - Day 1.Reader 122.2 percentage of regions
64Cu-SAR-BBNRegion-level PPV - Day 1.Reader 235.3 percentage of regions
64Cu-SAR-BBNRegion-level PPV - Day 1.Reader 337.5 percentage of regions
Primary

Safety and Tolerability

Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame: Up to 7 days post injection

Population: All Participants who received any amount of 64Cu-SAR-BBN.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
64Cu-SAR-BBNSafety and TolerabilityAny TEAE8 Participants
64Cu-SAR-BBNSafety and TolerabilityTEAE Grade 1 to 28 Participants
64Cu-SAR-BBNSafety and TolerabilityTEAE Grade 30 Participants
64Cu-SAR-BBNSafety and TolerabilityTEAE Grade 4 to 50 Participants
64Cu-SAR-BBNSafety and TolerabilityTEAE Related to 64Cu-SAR-BBN2 Participants
64Cu-SAR-BBNSafety and TolerabilitySerious TEAE0 Participants
64Cu-SAR-BBNSafety and TolerabilityTEAE Leading to Discontinuation of Study0 Participants
64Cu-SAR-BBNSafety and TolerabilityTEAE Leading to Death0 Participants
Secondary

Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0

The max Standardized Uptake Value (SUVmax) in lesions, visceral soft tissue and bone.

Time frame: Day 0 (1-4 hours) post injection

Population: All enrolled participants who received any amount of 64Cu-SAR-BBN who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.

ArmMeasureGroupValue (MEAN)Dispersion
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmax - Day 0Soft Tissue Lesions7.705 kg/LStandard Deviation 4.7952
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmax - Day 0All Lesions7.335 kg/LStandard Deviation 4.0904
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmax - Day 0Bone Lesions5.041 kg/L—
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0Soft Tissue Lesions5.910 kg/LStandard Deviation 3.8559
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0All Lesions5.314 kg/LStandard Deviation 3.1471
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0Bone Lesions4.144 kg/LStandard Deviation 1.8181
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0All Lesions14.436 kg/LStandard Deviation 27.7988
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0Bone Lesions5.013 kg/LStandard Deviation 3.6903
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0Soft Tissue Lesions16.368 kg/LStandard Deviation 29.7231
Secondary

Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1

The SUVmax in lesions, visceral soft tissue and bone.

Time frame: Day 1 (24 +/- 6 hours) post injection

Population: All enrolled participants who received any amount of 64Cu-SAR-BBN who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.

ArmMeasureGroupValue (MEAN)Dispersion
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmax - Day 1All Lesions4.179 kg/LStandard Deviation 3.3173
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmax - Day 1Soft Tissue Lesions4.179 kg/LStandard Deviation 3.3173
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1Soft Tissue Lesions2.930 kg/LStandard Deviation 4.1078
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1All Lesions2.762 kg/LStandard Deviation 3.5449
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1Bone Lesions5.017 kg/LStandard Deviation 6.2016
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1Soft Tissue Lesions3.965 kg/LStandard Deviation 4.5243
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1Bone Lesions1.945 kg/LStandard Deviation 0.8572
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1All Lesions2.763 kg/LStandard Deviation 3.2511
Secondary

Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0

The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue, bone.

Time frame: Day 0 (1-4 hours) post injection

Population: All enrolled participants who received any amount of 64Cu-SAR-BBN who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.

ArmMeasureGroupValue (MEAN)Dispersion
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmean - Day 0Soft Tissue Lesions5.699 kg/LStandard Deviation 3.538
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmean - Day 0All Lesions5.470 kg/LStandard Deviation 3.2058
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmean - Day 0Bone Lesions3.703 kg/L—
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0Soft Tissue Lesions4.362 kg/LStandard Deviation 2.905
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0All Lesions3.773 kg/LStandard Deviation 2.544
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0Bone Lesions2.482 kg/LStandard Deviation 1.2925
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0All Lesions5.671 kg/LStandard Deviation 8.0303
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0Bone Lesions2.353 kg/LStandard Deviation 2.0118
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0Soft Tissue Lesions6.427 kg/LStandard Deviation 8.5057
Secondary

Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1

The SUVmean in lesions, visceral soft tissue, bone.

Time frame: Day 1 (24 +/- 6 hours) post injection

Population: All enrolled participants who received any amount of 64Cu-SAR-BBN who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.

ArmMeasureGroupValue (MEAN)Dispersion
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmean - Day 1All Lesions2.586 kg/LStandard Deviation 1.9814
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVmean - Day 1Soft Tissue Lesions2.586 kg/LStandard Deviation 1.9814
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1Soft Tissue Lesions1.586 kg/LStandard Deviation 1.7712
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1All Lesions1.450 kg/LStandard Deviation 1.5305
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1Bone Lesions2.116 kg/LStandard Deviation 2.3684
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1Soft Tissue Lesions1.652 kg/LStandard Deviation 2.0244
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1Bone Lesions0.772 kg/LStandard Deviation 0.4263
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1All Lesions1.179 kg/LStandard Deviation 1.5309
Secondary

Biodistribution of 64Cu-SAR-BBN - SUVr - Day 0

Standardized Uptake Value Lesion to Background ratio (SUVr): SUVmax of the lesion divided by the SUVmean of gluteus background.

Time frame: Day 0 (1-4 hours) post injection

Population: All enrolled participants who received any amount of 64Cu-SAR-BBN who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.

ArmMeasureValue (MEAN)Dispersion
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVr - Day 014.566 ratioStandard Deviation 8.1016
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVr - Day 010.020 ratioStandard Deviation 5.1889
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVr - Day 013.442 ratioStandard Deviation 17.6749
Secondary

Biodistribution of 64Cu-SAR-BBN - SUVr - Day 1

SUVr: SUVmax of the lesion divided by the SUVmean of gluteus background.

Time frame: Day 1 (24 +/- 6 hours) post injection

Population: All enrolled participants who received any amount of 64Cu-SAR-BBN who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.

ArmMeasureValue (MEAN)Dispersion
64Cu-SAR-BBNBiodistribution of 64Cu-SAR-BBN - SUVr - Day 155.957 ratioStandard Deviation 36.4771
Reader 2Biodistribution of 64Cu-SAR-BBN - SUVr - Day 140.617 ratioStandard Deviation 24.7419
Reader 3Biodistribution of 64Cu-SAR-BBN - SUVr - Day 136.254 ratioStandard Deviation 45.2321
Secondary

Participant-level Detection Rate (DR)

Percentage of participants with a positive 64Cu-SAR-BBN PET/CT scan out of all participants with a 64Cu-SAR-BBN PET/CT scan for each timepoint and reader.

Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had a 64Cu-SAR-BBN PET/CT scan at the given timepoint.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNParticipant-level Detection Rate (DR)Reader 124.5 percentage of participants
64Cu-SAR-BBNParticipant-level Detection Rate (DR)Reader 243.4 percentage of participants
64Cu-SAR-BBNParticipant-level Detection Rate (DR)Reader 337.7 percentage of participants
Reader 2Participant-level Detection Rate (DR)Reader 117.0 percentage of participants
Reader 2Participant-level Detection Rate (DR)Reader 228.3 percentage of participants
Reader 2Participant-level Detection Rate (DR)Reader 337.7 percentage of participants
Secondary

Participant-level Discrepant PET Negativity Rate

Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.

Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN with 64Cu-SAR-BBN PET/CT imaging results from at least one central reader and had a positive reference standard on the participant level.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNParticipant-level Discrepant PET Negativity RateReader 126.3 percentage of participants
64Cu-SAR-BBNParticipant-level Discrepant PET Negativity RateReader 215.8 percentage of participants
64Cu-SAR-BBNParticipant-level Discrepant PET Negativity RateReader 310.5 percentage of participants
Secondary

Participant-level False Positive Rate (FPR)

Percentage of false positive (FP) participants out of all participants with a positive scan, derived separately for each timepoint and reader.

Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNParticipant-level False Positive Rate (FPR)Reader 141.7 percentage of participants
64Cu-SAR-BBNParticipant-level False Positive Rate (FPR)Reader 268.2 percentage of participants
64Cu-SAR-BBNParticipant-level False Positive Rate (FPR)Reader 363.2 percentage of participants
Reader 2Participant-level False Positive Rate (FPR)Reader 166.7 percentage of participants
Reader 2Participant-level False Positive Rate (FPR)Reader 261.5 percentage of participants
Reader 2Participant-level False Positive Rate (FPR)Reader 356.3 percentage of participants
Secondary

Participant-level PPV

Percentage of TP participants out of all positive participants, derived separately for each timepoint and reader.

Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNParticipant-level PPVReader 158.3 percentage of participants
64Cu-SAR-BBNParticipant-level PPVReader 231.8 percentage of participants
64Cu-SAR-BBNParticipant-level PPVReader 336.8 percentage of participants
Reader 2Participant-level PPVReader 133.3 percentage of participants
Reader 2Participant-level PPVReader 238.5 percentage of participants
Reader 2Participant-level PPVReader 343.8 percentage of participants
Secondary

Participant-level True Negative Rate (TNR)

Percentage of true negative (TN) participants on the Day 0 or Day 1 scan out of all participants with a negative Day 0 or Day 1 scan.

Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNParticipant-level True Negative Rate (TNR)Reader 182.1 percentage of participants
64Cu-SAR-BBNParticipant-level True Negative Rate (TNR)Reader 257.1 percentage of participants
64Cu-SAR-BBNParticipant-level True Negative Rate (TNR)Reader 358.6 percentage of participants
Reader 2Participant-level True Negative Rate (TNR)Reader 185.7 percentage of participants
Reader 2Participant-level True Negative Rate (TNR)Reader 277.1 percentage of participants
Reader 2Participant-level True Negative Rate (TNR)Reader 369.0 percentage of participants
Secondary

Region-level FPR

Percentage of FP regions on the Day 0 or Day 1 scan out of all positive regions, derived separately for each timepoint and reader.

Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNRegion-level FPRReader 152.9 percentage of regions
64Cu-SAR-BBNRegion-level FPRReader 277.4 percentage of regions
64Cu-SAR-BBNRegion-level FPRReader 366.7 percentage of regions
Reader 2Region-level FPRReader 177.8 percentage of regions
Reader 2Region-level FPRReader 264.7 percentage of regions
Reader 2Region-level FPRReader 362.5 percentage of regions
Secondary

Region-level TNR

Percentage of TN regions on the Day 0 or Day 1 scan out of all negative regions on the Day 0 or Day 1 scan.

Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint.

ArmMeasureGroupValue (NUMBER)
64Cu-SAR-BBNRegion-level TNRReader 195.8 percentage of regions
64Cu-SAR-BBNRegion-level TNRReader 288.2 percentage of regions
64Cu-SAR-BBNRegion-level TNRReader 392.6 percentage of regions
Reader 2Region-level TNRReader 196.7 percentage of regions
Reader 2Region-level TNRReader 294.6 percentage of regions
Reader 2Region-level TNRReader 393.0 percentage of regions

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026