Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma

June 21, 2022 updated by: Fuad Novruzov, The National Center of Oncology, Azerbaijan
The aim of this study is to compare the diagnostic performance of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT in primary and metastatic lesions of breast cancer and to reveal the best diagnostic imaging time of 68Ga-FAPI-46 PET/CT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants with breast carcinoma will undergo contemporaneous 18F-FDG and 68Ga-FAPI PET/CT. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT will be calculated and compared to evaluate the diagnostic efficacy. In addition, best diagnostic imaging time of 68Ga-FAPI-46 PET/CT will be evaluated at 10th, 30th and 60th minute scan time.

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Locations

  • Azerbaijan
      • Baku, Azerbaijan, AZ1011
        • Recruiting
        • National Centre of Oncology
        • 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

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • adult participants (aged 18 years or order);
  • participants with newly diagnosed breast carcinoma;
  • pathology confirmed by lesion tru-cut biopsy;
  • participants who were able to provide informed consent.

Exclusion Criteria:

  • participants with non-malignant lesions;
  • participants with pregnancy;
  • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

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: 68Ga-FAPI-46 PET/CT + 18-FDG PET/CT
18FDG PET/CT scan is followed by [68Ga]FAPI-46 PET/CT within 2-3 days.
Diagnostic test: 68Ga-FAPI-46 PET/CT
Patients are scanned 10 minute, 30 minute and 1 hour after 68Ga-FAPI-46 as well as one hour 18-FDG injection within 2-3 days interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum standardised uptake value [SUVmax] for primary lesion
Time Frame: 2-3 days
SUVmax of 68Ga-FAPI PET/CT for breast carcinoma in comparison with SUVmax value of 18F-FDG PET/CT
2-3 days
Best diagnostic imaging time of 68GaFAPI-46 PET/CT
Time Frame: 2-3 days
Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time
2-3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy for breast carcinomas
Time Frame: 2 days
Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for breast carcinomas in comparison with 18F-FDG PET/CT
2 days
SUVmax for metastatic lymph nodes
Time Frame: 2 days
SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
2 days
Diagnostic efficacy for metastatic lymph nodes
Time Frame: 2 days
Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
2 days
Correlation between tumor SUVmax values and pathology grade
Time Frame: 2 days
Correlation between tumor SUVmax values and pathology grade calculated
2 days

Collaborators and Investigators

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

Sponsor

The National Center of Oncology, Azerbaijan

Collaborators

SOFIE INC

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)

February 4, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCO-21001

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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