Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors

Official Title: A Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Patients With Solid Tumors

Study ID: NCT05784597

Conditions

Breast Cancer

Colorectal Cancer

Oesophageal Cancer

Pancreas Adenocarcinoma

Interventions

[68Ga]Ga-OncoFAP administration

Study Description

Brief Summary: The primary objectives of this trial are to evaluate the safety and dosimetry of \[68Ga\]Ga-OncoFAP for detection/imaging of solid tumors.

Detailed Description: Phase I, multicenter study in patients with a confirmed diagnosis of solid tumor among breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma, requiring clinical staging for nodal staging and/or metastatic disease (based on institutional practice and risk stratification). All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq). \[68Ga\]Ga-OncoFAP biodistribution, PK, and dosimetry of \[68Ga\]Ga-OncoFAP will be assessed based on a series of PET/CT scans, blood and urine sampling.