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Clinical Trials in the EU / 2025-524942-87-00
Authorised Phase IV

Prognostic value of early assessment by ⁶⁸Ga-DOTATATE PET/CT for the treatment of well-differentiated grade 2 gastroenteropancreatic neuroendocrine tumors with ¹⁷⁷Lutetium-oxodotreotide.”

2025-524942-87-00 · tracked via the Priya Life Science EU tracker
Sponsor
Centre De Lutte Contre Le Cancer Eugene Marquis
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Neoplasms
Decision date
18/05/2026
Enrollment target
40
Sites
France

Condition studied

Gastroenteropancreatic neuroendocrine tumors

Investigational medicinal product(s)

SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Progression-free survival is defined as the time from the first injection of ¹⁷⁷Lu-oxodotreotide to the occurrence of the first documented tumor progression according to RECIST 1.1 criteria during CT follow-up.

Endpoint detail

Progression-free survival is defined as the time from the first injection of ¹⁷⁷Lu-oxodotreotide to the occurrence of the first documented tumor progression according to RECIST 1.1 criteria during CT follow-up. Tumor assessment is performed every 3 months after treatment initiation using CT and RECIST 1.1 criteria. ⁶⁸Ga-edotreotide PET/CT images acquired immediately before the third injection of ¹⁷⁷Lu-oxodotreotide will be independently analyzed

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524942-87-00 on CTIS ↗ ← All trials in the EU