Neuroendocrine Tumors
Conditions
Brief summary
This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer.
Detailed description
In total, 59 subjects will be recruited in the study. The study will recruit both healthy volunteers as well as patients with confirmed or suspicious NET disease by histology or conventional anatomical and functional imaging modalities including but not limited to magnetic resonance imaging (MRI), and/or computed tomography (CT), and/or, F-18 FDG fluorodeoxyglucose PET (positron emission tomography)/CT and /or F-18 NaF sodium fluoride bone PET/CT and/or bone scintigraphy, and/or Octreoscan.
Interventions
DRUG64Cu-DOTATATE
Detection of somatostatin positive lesions in NET
Sponsors
Radiomedix, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Confirmed or suspicion of NET based on histology/ biopsy report. * Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET * CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date.
Exclusion criteria
* Pregnant, planning to be pregnant within the next two weeks * Inability to provide written consent. * Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor | 12 months | The number of patients with NETs disease that was confirmed by SSTR(+) imaging using 64Cu-DOTATATE PET/CT and In111-Octreoscan (considered as the standard of truth imaging) A total of 63 subjects have been enrolled in the studies; among them 42 patients with known or suspected NET based on histology, or conventional imaging, or clinical evaluations and 21 healthy volunteers. |
| Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor | 12 months | The number of subjects who have no SSTR (+) NETs as determined by 64Cu-DOTATATE PET/CT as well using the standard of truth imaging (In111-Octrescan SPECT/CT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging | 12 months | The number of patients with localized NETs or metastatic SSTR(+) neuroendocrine tumors that were detected by both 64Cu-DOTATATE and SOT |
Countries
United States
Participant flow
Recruitment details
Number of Subjects (planned and analyzed): 63 Analyzed: In total, 63 subjects (59 from the Phase 3 study and 4 from the Phase 1 study) were injected with study drug at an intended dose of 4.0 mCi and met the criteria to be analyzed for safety and efficacy.
Participants by arm
| Arm | Count |
|---|---|
| PET/CT Imaging With 64Cu-DOTATATE 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells.
64Cu-DOTATATE: Detection of somatostin positive lesions in NET | 63 |
| Total | 63 |
Baseline characteristics
| Characteristic | PET/CT Imaging With 64Cu-DOTATATE |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Age, Continuous | 54.37 years STANDARD_DEVIATION 15.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 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 | 1 Participants |
| Race (NIH/OMB) White | 54 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 5 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
Primary
Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor
The number of patients with NETs disease that was confirmed by SSTR(+) imaging using 64Cu-DOTATATE PET/CT and In111-Octreoscan (considered as the standard of truth imaging) A total of 63 subjects have been enrolled in the studies; among them 42 patients with known or suspected NET based on histology, or conventional imaging, or clinical evaluations and 21 healthy volunteers.
Time frame: 12 months
Population: The number of patients with SSTR(+) NETs identified using 64Cu-DOTATATE PET-CT imaging as well as by the standard of truth methods.~A total of 63 subjects have been enrolled in the studies, including 42 patients with known or suspected NET based on histology, conventional imaging, or clinical evaluations and 21 healthy volunteers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PET/CT Imaging With 64Cu-DOTATATE | Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor | true positive | 30 Participants |
| PET/CT Imaging With 64Cu-DOTATATE | Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor | false negative | 3 Participants |
Primary
Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor
The number of subjects who have no SSTR (+) NETs as determined by 64Cu-DOTATATE PET/CT as well using the standard of truth imaging (In111-Octrescan SPECT/CT).
Time frame: 12 months
Population: The specificity of 64Cu-DOTATATE imaging has defined the ability of a radiotracer to correctly identify subjects who do not have a disease. It is defined by number of subjects who had no SSTR(+) NETs based on 64Cu-DOTATATE PET/CT imaging as well as SOT imaging using In111-Octreoscan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PET/CT Imaging With 64Cu-DOTATATE | Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor | true negative | 28 Participants |
| PET/CT Imaging With 64Cu-DOTATATE | Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor | false positive | 1 Participants |
Secondary
Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging
The number of patients with localized NETs or metastatic SSTR(+) neuroendocrine tumors that were detected by both 64Cu-DOTATATE and SOT
Time frame: 12 months
Population: A number of subjects with localized SSTR(+) NETs or metastatic NETs detected by both Cu64-DOTATATE and SOT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PET/CT Imaging With 64Cu-DOTATATE | Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging | localized NETs true positive | 2 Participants |
| PET/CT Imaging With 64Cu-DOTATATE | Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging | localized NEts false negative | 0 Participants |
| PET/CT Imaging With 64Cu-DOTATATE | Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging | metastatic NETs false positive | 0 Participants |
| PET/CT Imaging With 64Cu-DOTATATE | Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging | metastatic NETs true negative | 28 Participants |