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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04441606

Enrollment

Registered

2020-06-22

Start date

2020-06-11

Completion date

2021-07-31

Last updated

2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Different Types of Cancer

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.

Interventions

RADIATION68Ga-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Israel

Contacts

Primary ContactIRA DANA

irako@tlvmc.gov.il+97236974373

Backup ContactYANA ABRAMOV