Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients

Status: Active_not_recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Canada
BC Cancer
Vancouver
Time Frame
Start Date: 2018-07-11
Completion Date: 2028-09-30
Participants
Target number of participants: 800
Treatments
PET/CT Diagnostic Imaging
Each subject will have two PET/CT scans, one using 68Ga-DOTATOC and the other using 18F-FDG. The 68Ga-DOTATOC radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada.
Sponsors
Leads: British Columbia Cancer Agency

This content was sourced from clinicaltrials.gov