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

February 8, 2021 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky medial center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Different types of cancer

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.
Radiation: 68Ga-FAPI-04 PET/CT
  • Patients will undergo two scans: first a routine FDG PET scan and a FAPI PET scan, within 10 days.
  • Scans will be interpreted by board certified Nuclear medicine physicians and board certified radiologists.
  • Immunohistochemical analysis with specific staining for FAP will be performed in removed malignant tissues, either at surgery or from biopsy, to assess a possible correlation between the intensity of uptake and the level of FAP expression.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

June 17, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-20-ES-0308-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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