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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-11

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Different Types of Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

68Ga-FAPI-04 PET/CT

Intervention Type RADIATION

* 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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.