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

• Sponsor: The National Center of Oncology, Azerbaijan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05339113
• Collaborator: SOFIE INC (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.8
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms; Positron Emission Tomography; Fibroblast Activation Protein Inhibitor; Fluorodeoxyglucose F18	Diagnostic Test: 68Ga-FAPI-46 PET/CT	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
• Actual Study Start Date: Feb 4, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Maximum standardised uptake value [SUVmax] for primary lesion [2-3 days]

   SUVmax of 68Ga-FAPI PET/CT for breast carcinoma in comparison with SUVmax value of 18F-FDG PET/CT

2. Best diagnostic imaging time of 68GaFAPI-46 PET/CT [2-3 days]

   Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time

Secondary Outcome Measures

1. Diagnostic efficacy for breast carcinomas [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. SUVmax for metastatic lymph nodes [2 days]

   SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT

3. Diagnostic efficacy for metastatic lymph nodes [2 days]

   Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT

4. Correlation between tumor SUVmax values and pathology grade [2 days]

   Correlation between tumor SUVmax values and pathology grade calculated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Centre of Oncology	Baku		Azerbaijan	AZ1011

Sponsors and Collaborators

• The National Center of Oncology, Azerbaijan
• SOFIE INC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fuad Novruzov, Head of Nuclear Medicine Department, The National Center of Oncology, Azerbaijan
• ClinicalTrials.gov Identifier: NCT05339113
• Other Study ID Numbers: NCO-21001
• First Posted: Apr 21, 2022
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; FAPI-46

Study Results

No Results Posted as of Jun 24, 2022