18F-FDOPA PET in Neuroendocrine Tumours

NCT02431715 | Unknown

• 1 other identifier: H12-01795
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Neuroendocrine tumours (NETs) are a group of neoplasms generally arising from the gastroenteropancreatic tract. They are usually slow growing, have low malignant potential, and often go unnoticed until they become metastatic. The correct treatment approach is dependent on the extent of the disease, however surgical approaches and systemic therapy can be curative. Combined positron emission tomography/computed tomography (PET/CT) using the radiotracer 18F-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) has been shown to be a promising non-invasive technique to help localizing NETs and guide their treatment.

Conditions

Thyroid Cancer, Medullary; Carcinoid Tumor; Pheochromocytoma; Paraganglioma; Insulinoma; Neuroblastoma

Interventions

[18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) DRUG

All patients will have their weight and baseline vital signs recorded. The study subject will have an intravenous catheter inserted and receive a slow bolus intravenous dose of 185 - 370 MBq (5 -10mCi) 18F-FDOPA. The patient will rest in a comfortable reclining chair in a warm, private shielded room for 45 to 60 minutes. Patients are positioned supine and centered on the scanner bed for an average total scan time (CT and PET) of approximately 30 minutes. Images will be interpreted by qualified and experienced physicians. Findings of significance from the PET/CT scan, and any incidental findings of significance from the CT scan, will be included in the single final report that will be issued to referring physicians.

Also known as: 18F-FDOPA

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the BCCA approved clinical indications for 18F-FDOPA PET/CT scans in neuroendocrine tumours.
• ECOG performance status 0 - 3.
• Able to provide written informed consent (or consent by guardian for subjects \<19 years).
• Referred by a treating BC physician.
• Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 40 minutes and tolerating intravenous cannulation for injection.

You may not qualify if:

• Pregnancy.
• Patients who are medically unstable eg. 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 70 cm).

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Thyroid cancer, medullary; Carcinoid Tumor; Pheochromocytoma; Paraganglioma; Insulinoma; Neuroblastoma

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Adenoma, Islet Cell; Adenoma; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 1, 2015
• Last Updated: February 21, 2023

Record last verified: 2022-11

Locations

CA (1)