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68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02440308
Enrollment
10
Registered
2015-05-12
Start date
2015-04-30
Completion date
2015-06-30
Last updated
2017-04-11

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

Conditions

Prostate Carcinoma

Brief summary

This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is lighting up and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2). OUTLINE: Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 1 hour later. After completion of study, patients are followed up at 24 hours and 1 week.

Interventions

DRUG68Ga-DOTA-Bombesin

68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is \[4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl\]-acetyl. 68Ga-DOTA-Bombesin is administered intravenously (IV)

PROCEDUREMagnetic Resonance Imaging (MRI) scan
PROCEDUREPositron Emission Tomography (PET) scan

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

Inclusion criteria

* Provides written informed consent * Known diagnosis of prostate cancer * Patient has suspected recurrence based on biochemical data \[prostate-specific antigen (PSA) \> 2 ng/mL\] * Able to remain still for duration of each imaging procedure (about one hour)

Exclusion criteria

* Unable to provide informed consent * Inability to lie still for the entire imaging time * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance * Metallic implants

Design outcomes

Primary

MeasureTime frameDescription
Normal Biodistribution of 68Ga-DOTA-Bombesin1 hourRadiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.

Secondary

MeasureTime frameDescription
68Ga-DOTA-Bombesin FeasibilityUp to 1 weekFeasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.

Countries

United States

Participant flow

Participants by arm

ArmCount
68Ga-DOTA-Bombesin PET/MRI
Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
10
Total10

Baseline characteristics

Characteristic68Ga-DOTA-Bombesin PET/MRI
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
9 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
Age, Continuous73.3 years
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Normal Biodistribution of 68Ga-DOTA-Bombesin

Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.

Time frame: 1 hour

Population: All participants were averaged to provide SUVmean uptake in normal organs.

ArmMeasureGroupValue (MEAN)Dispersion
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinChoroid plexus0.25 SUV-meanStandard Deviation 0.16
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinLung0.48 SUV-meanStandard Deviation 0.16
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinAscending aorta (blood pool)2.28 SUV-meanStandard Deviation 0.68
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinBladder121.55 SUV-meanStandard Deviation 67.45
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinBrain cortex (frontal lobe)0.08 SUV-meanStandard Deviation 0.04
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinCerebellum0.10 SUV-meanStandard Deviation 0.05
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinCervical vertebrae0.70 SUV-meanStandard Deviation 0.19
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinColon2.01 SUV-meanStandard Deviation 0.74
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinEsophagus4.08 SUV-meanStandard Deviation 1.51
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinExtra focal uptakes12.72 SUV-meanStandard Deviation 7.77
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinFemur0.34 SUV-meanStandard Deviation 0.12
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinLiver1.94 SUV-meanStandard Deviation 0.48
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinGluteal fat0.60 SUV-meanStandard Deviation 0.19
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinGluteal muscle0.79 SUV-meanStandard Deviation 0.41
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinHumerus0.53 SUV-meanStandard Deviation 0.17
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinKidney9.51 SUV-meanStandard Deviation 6.15
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinLumbar vertebrae0.75 SUV-meanStandard Deviation 0.28
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinPancreas52.02 SUV-meanStandard Deviation 16.74
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinParotid gland0.99 SUV-meanStandard Deviation 0.23
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinSacrum0.69 SUV-meanStandard Deviation 0.36
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinSpleen1.62 SUV-meanStandard Deviation 0.49
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinSmall bowel2.40 SUV-meanStandard Deviation 0.57
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinStomach2.48 SUV-meanStandard Deviation 0.73
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinSubmandibular gland1.18 SUV-meanStandard Deviation 0.45
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinThoracic vertebrae0.91 SUV-meanStandard Deviation 0.32
68Ga-DOTA-Bombesin PET/MRINormal Biodistribution of 68Ga-DOTA-BombesinThyroid1.31 SUV-meanStandard Deviation 0.29
Secondary

68Ga-DOTA-Bombesin Feasibility

Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.

Time frame: Up to 1 week

Population: Includes all participants enrolled.

ArmMeasureValue (NUMBER)
68Ga-DOTA-Bombesin PET/MRI68Ga-DOTA-Bombesin Feasibility100 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026