Characterizing Breast Cancer With Al18F-NOTA-FAPI-04 PET/CT (PFB-02)

December 22, 2023 updated by: Peking Union Medical College Hospital

Accuracy and Safety of Al18F-NOTA-FAPI-04 PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study

Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. Previous studies have demonstrated that FAPI PET/CT performs well in cases of epithelial tumors, including breast cancer. This prospective study is going to investigate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is a complex, heterogeneous disease comprising numerous distinct biological subtypes characterized by variant pathobiological features and clinical behaviors. 18F-fluorodeoxyglucose (18F-FDG) PET/CT, an essential imaging modality in the characterization of metabolism within the tumor, has successfully evolved in the diagnosis, staging, and assessment of treatment response in patients with breast cancer. Cancer-associated fibroblasts (CAFs) are a crucial component of the tumor stroma with diverse functions. Fibroblast activation protein (FAP), a type II membrane-bound glycoprotein from the dipeptidyl peptidase-4 family, is highly expressed in the CAFs of several epithelial carcinomas, including breast cancer, coupled with relatively low expression in normal tissue. Based on this characteristic, many small-molecule inhibitors of FAP (FAPIs) labeled with radioactive tracers (68Ga, 18F, or 177Lu) have been synthesized as theranostic radiotracers for cancer. Previous studies on FAPI PET/CT tumor imaging have focused on the 68Ga radionuclide rather than 18F. As 18F-labeled FAPI has more favorable physical properties, high production capacity, and good imaging characteristics, it may be an ideal agent for PET imaging. Therefore, this study aims to evaluate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.

Study Type

Interventional

Enrollment (Actual)

88

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 18-80 years old;
  • newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG;
  • BC clinical stagecT1-3 cN0-3 M0;
  • no prior treatment for BC.

Exclusion Criteria:

  • pregnancy;
  • breastfeeding;
  • patients who were unwilling to undergo PET/CT scans.

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: Al18F-NOTA-FAPI-04 PET/CT
Inject Al18F-NOTA-FAPI-04 and then perform PET/CT scan.
Diagnostic test: Al18F-NOTA-FAPI-04 PET/CT scan
Patients enrolled underwent PET/CT after injection of Al18F-NOTA-FAPI-04 to image lesions of breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance (1)
Time Frame: Through study completion, an average of 1 year
Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of Al18F-NOTA-FAPI-04 PET/CT in the detection of ALN metastasis according to the pathological reference standard on a per-patient basis, compared with 18F-FDG PET/CT and ultrasound.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Stage
Time Frame: Through study completion, an average of 1 year
Clinical stage changed by Al18F-NOTA-FAPI-04 PET/CT compared to 18F-FDG PET/CT.
Through study completion, an average of 1 year
Diagnostic Performance (2)
Time Frame: Through study completion, an average of 1 year
Diagnostic performance of ALN metastasis of Al18F-NOTA-FAPI-04 PET/CT with or without previous biopsy on breast lesion.
Through study completion, an average of 1 year
Safety
Time Frame: Through study completion, an average of 1 year
Short-term adverse effects (AEs) after Al18F-NOTA-FAPI-04 injection.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Li Huo, M.D., Peking Union Medical College Hospital

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)

May 10, 2022

Primary Completion (Actual)

October 31, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUMCH-FAPI-BC-2

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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