Comparison of PET (radiological test) with 18F-FDG and with 68Ga-DOTA-peptides in advanced neuroendocrine tumors

Phase 1

• Conditions: Gastroenteropancreatic neuroendocrine tumor disease; MedDRA version: 20.0 Level: LLT Classification code 10077560 Term: Gastroenteropancreatic neuroendocrine tumor disease System Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2018-000398-64-ES
• Lead Sponsor: Vall d' Hebron Institute of Oncology (VHIO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-20
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

The study population will be composed of 30 patients with metastatic NET. A total of 15 patients with primary pancreatic tumor and 15 with primary extra-pancreatic tumor will be included.

1. Age > 18 years.
2. Signed informed consent form.
3. Grade 1 and 2 NETs according to WHO and ENETS classification.
4. Metastatic NETs.
5. Life expectancy > 12 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Grade 3 NET according to WHO and ENETS classification.
2. Previous systemic radiopharmaceutical therapy.
4. Pregnancy
5. High-risk disease (cardiovascular, pulmonary...)
6. Chronic liver disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified