Using advanced imaging to detect neuroendocrine tumors
Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients
British Columbia Cancer Agency · NCT03583528
This study is testing a new type of PET/CT scan to see if it can better detect neuroendocrine tumors compared to the standard scan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | British Columbia Cancer Agency (other) |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT03583528 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Gallium-DOTATOC PET/CT imaging in detecting neuroendocrine tumors (NETs) compared to standard imaging techniques. Participants will undergo two PET/CT scans: one with the experimental 68Ga-DOTATOC tracer and another with the standard 18F-FDG tracer. The study aims to assess the safety and sensitivity of the new imaging method in identifying tumors that over-express somatostatin receptors. Follow-up assessments will track patient outcomes and any adverse events for up to three years.
Who should consider this trial
Good fit: Ideal candidates include patients with neuroendocrine tumors or other tumors that may over-express somatostatin receptors and require imaging for staging or re-staging.
Not a fit: Patients who are pregnant or medically unstable may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could lead to earlier and more accurate detection of neuroendocrine tumors, improving patient management and treatment outcomes.
How similar studies have performed: While similar imaging techniques have been explored, the specific use of 68Ga-DOTATOC PET/CT for NETs is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Vancouver, British Columbia
- BC Cancer — Vancouver, British Columbia, Canada (RECRUITING)
Study contacts
- Principal investigator: Francois Benard, MD — BC Cancer
- Study coordinator: Research Project Manager
- Email: MITclinicaltrials@bccancer.bc.ca
- Phone: 604-675-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuroendocrine Tumors, Insulinoma, Gastrinoma, Glucagonoma, Vipoma, Pheochromocytoma, Paraganglioma, Neuroblastoma