The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies

Not Applicable

• Conditions: Different Types of Cancer
• Interventions: Radiation: 68Ga-FAPI-04 PET/CT

• Registration Number: NCT04441606
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on malignancies known to show variable avidity to FDG and at times, no uptake at all. Also patients unable to optimally comply with the required preparation for FDG imaging, such as diabetic patients who struggle in achieving glycemic control.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-11
• Study First Submitted: 2020-06-14
• Primary Completion: 2020-06-17
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-11
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:

1. Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.

2. Better delineation of tumor extent prior to therapy

3. Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).

4. Patients unable to optimally comply with the required preparation for FDG imaging.

   • The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff.

Exclusion Criteria

• Age < 18 years.
• Pregnant females.
• Patients who are reluctant to undergo both FDG and FAPI PET scans.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Different types of cancer	68Ga-FAPI-04 PET/CT	The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to: 1. Inconclusive findings on 18F-FDG PET/CT or other imaging modalities. 2. Better delineation of tumor extent prior to therapy 3. Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma). 4. Patients unable to optimally comply with the required preparation for FDG imaging. * The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff.

Primary Outcome Measures

Name	Time	Method
Patients who preformed 68Ga-FAPI-04 PSMA.	1 year	To evaluate the avidity of various cancers to 68Ga-FAPI-04.
Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG.	1 year	To compare the detectability of FAPI-04 and FDG for malignant lesions.
Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI.	1 year	To evaluate the potential impact of 68Ga-FAPI-04 PET/CT and/or PET/MRI on patient management.

Trial Locations

Locations (1)

Tel Aviv Sourasky medial center; 🇮🇱 Tel Aviv, Israel