Neuroblastoma Clinical Trial
Official title:
Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients
NCT number | NCT03583528 |
Other study ID # | H17-00909 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 11, 2018 |
Est. completion date | December 31, 2028 |
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs. This study proposes 68Gallium(68Ga)-DOTATOC positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the safety and sensitivity of 68Ga-DOTATOC PET/CT at detecting NETs and other tumors with over-expression of somatostatin receptors.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: All subjects: - World health organization performance status 0-2 - Able to provide written informed consent/assent (or consent by guardian for subjects <19 years) - Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 30 minutes and tolerating intravenous cannulation for injection. Patients must require imaging for either staging or re-staging of: - Gastroenteropancreatic tumors (e.g. carcinoids, gastrinoma, insulinoma, glucagonoma, VIPoma, etc.), functioning and non-functioning - Sympathoadrenal system tumors (phaeochromocytoma, paraganglioma, neuroblastoma, ganglioneuroma) - Medullary thyroid carcinoma - Pituitary adenoma - Medulloblastoma - Merkel cell carcinoma - Small-cell lung cancer (mainly primary tumors) - Meningioma - Or any other NET / with potential for overexpression of SSTR Exclusion Criteria: - Pregnancy - Patients who are medically unstable ex: acute cardiac or respiratory distress, hypotensive - Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70cm). |
Country | Name | City | State |
---|---|---|---|
Canada | BC Cancer | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumors. | Determination of sensitivity of both exams when compared with pathology reports (if available) and compared with routine imaging (CT, MRI, Octreoscan™, US) if available and will be determined by confidence intervals using an exact binominal distribution by comparing the 68Ga-DOTATOC PET/CT with 18F-FDG and conventional imaging (if available).
The gold standard for the detection of lesions will be established through a combination of: 1) pathology; 2) unequivocal correlative imaging results as assessed independently by 2 physicians; 3) disease progression of specific findings upon follow-up, up to three years from baseline examination; 4) a clearly unequivocal plurimetastatic pattern confirmed by any imaging modality at any of the involved sites; 5) response of lesions on subsequent imaging following therapy. |
3 years | |
Secondary | Number of participants with 68Ga-DOTATOC-related adverse events as assessed by abnormal vital sign measurement. | Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at three time points (before and after injection, and 1 hour after the injection). All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event. | 1 hour | |
Secondary | Number of participants with self-reported 68Ga-DOTATOC-related adverse event | Patients will be contacted by phone 24 hours after the 68Ga-DOTATOC PET/CT scan to see if they experienced any adverse events. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report. | 24 hours | |
Secondary | Total number of lesions per anatomic location identified by 68Ga-DOTATOC PET/CT | All lesions will be tabulated and classified by compartment (pancreas, liver, bowel, lung and mediastinum, abdomen and retroperitoneal lymph nodes, bone, other) for all imaging modalities that have been done for that subject. A total number of lesions (for all modalities) will be calculated and a proportion of lesions detected by each modality will be reported and will be compared by calculating the median and its confidence interval. This will assess the efficacy of 68Ga-DOTATOC PET/CT. | 3 years |
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