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

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: Different Types of Cancer
• Intervention / Treatment: Radiation: 68Ga-FAPI-04 PET/CT

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: IRA DANA; Phone Number: +97236974373; Email: irako@tlvmc.gov.il
• Study Contact Backup: Name: YANA ABRAMOV; Phone Number: +97236974373; Email: irako@tlvmc.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Sourasky medial center
    • Contact: IRA DANA; Phone Number: +97236974373; Email: irako@tlvmc.gov.il
    • Contact: YANA ABRAMOV; Phone Number: +97236974373; Email: irako@tlvmc.gov.il

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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: Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.; Better delineation of tumor extent prior to therapy; 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).; 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.	To evaluate the avidity of various cancers to 68Ga-FAPI-04.	1 year
Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG.	To compare the detectability of FAPI-04 and FDG for malignant lesions.	1 year
Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI.	To evaluate the potential impact of 68Ga-FAPI-04 PET/CT and/or PET/MRI on patient management.	1 year

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

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: Neoplasms
• 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