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

Different Types of Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441606
• Other study ID #: TASMC-20-ES-0308-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: July 2021

Study information

• Verified date: June 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: IRA DANA
• Phone: +97236974373
• Email: irako[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2021
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Different Types of Cancer
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky medial center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients who preformed 68Ga-FAPI-04 PSMA.	To evaluate the avidity of various cancers to 68Ga-FAPI-04.	1 year
Primary	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
Primary	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