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

Patterns of uptake of 18F-FDG and 68Ga-DOTA PET in advanced neuroendoctrine tumors

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000398-64-ES

Enrollment

Registered

2018-04-20

Start date

2018-06-18

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteropancreatic neuroendocrine tumor disease MedDRA version: 20.0 Level: LLT Classification code 10077560 Term: Gastroenteropancreatic neuroendocrine tumor disease System Organ Class: 100000004864

Interventions

Trade Name: SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation Pharmaceutical Form: Kit for radiopharmaceutical preparation INN or Proposed INN: Edotreot

Eligibility

Sex/Gender

All

Inclusion criteria

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. Inclusion criteria: 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

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Not applicable; Primary end point(s): 1. Number of new lesions detected with PET-CT with 68Ga-DOTA compared to PET-CT with 18F-FDG. 2. Number of affected organs detected with PET-CT with 68Ga-DOTA compared to PET-CT with 18F-FDG ;Timepoint(s) of evaluation of this end point: Both comparative imaging studies will be performed after having performed both tests in each of the patients included in the trial.; Main Objective: 1-To determine the sensitivity of 68Ga-DOTA PET-CT to detect tumors with high expression of RSST as compared to that of standard of care with octreotide labeled with gamma-emitting radionuclides 2- To identify the uptake patterns of 18F-FDG and 68Ga-DOTA PET-CT within subjects with well or moderately differentiated metastatic GEP-NET (ENETS grades 1 and 2). 3-To establish the correlation between the functional characteristics of hepatic lesions and the level of uptake of 18F-FDG and 68Ga. 4-To explore the impact of this combined imaging test on therapeutics.	—

Measure

Time frame

Secondary Objective: Not applicable; Primary end point(s): 1. Number of new lesions detected with PET-CT with 68Ga-DOTA compared to PET-CT with 18F-FDG. 2. Number of affected organs detected with PET-CT with 68Ga-DOTA compared to PET-CT with 18F-FDG ;Timepoint(s) of evaluation of this end point: Both comparative imaging studies will be performed after having performed both tests in each of the patients included in the trial.; Main Objective: 1-To determine the sensitivity of 68Ga-DOTA PET-CT to detect tumors with high expression of RSST as compared to that of standard of care with octreotide labeled with gamma-emitting radionuclides 2- To identify the uptake patterns of 18F-FDG and 68Ga-DOTA PET-CT within subjects with well or moderately differentiated metastatic GEP-NET (ENETS grades 1 and 2). 3-To establish the correlation between the functional characteristics of hepatic lesions and the level of uptake of 18F-FDG and 68Ga. 4-To explore the impact of this combined imaging test on therapeutics.

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

Spain

Contacts

Public ContactClinical Research Support Unit

Vall d' Hebron Institute of Oncology (VHIO)

smunoz@vhio.net34932 543 4508614

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026