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Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05856409
Collaborator
(none)
20
Enrollment
1
Location
31.7
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective study to investigate the potential efficacy of 68Ga-FAPI PET/CT for recurrence detection of epithelial ovarian cancer in comparison with 18F-FDG PET/CT.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 68Ga-FAPI

Detailed Description

Gallium 68-labeled fibroblast-activation protein inhibitor (68Ga-FAPI) has recently been a potential radiotracer for gynecological malignancies,including ovarian cancer. Early detection and localization of sites of recurrence helps to identify ovarian cancer patients who will benefit the most from secondary surgery, chemotherapy, or radiation therapy. Its clinical utility for recurrence detection of epithelial ovarian cancer and histological validation of FAPI findings is not well established.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence
Anticipated Study Start Date :
May 10, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. Diagnostic Performance [1 year]

    Sensitivity and Specificity of 68Ga-FAPI PET/CT for recurrence in comparison with 18F-FDG PET/CT

  2. Maximum standardized uptake value（SUVmax） [1 year]

    Measurement of the maximum standardized uptake value of the lesion

  3. Tumor-to-background ratio (TBR) [1 year]

    TBR was calculated according to the formula：TBR=SUVmax of lesion/SUVmax of background

Secondary Outcome Measures

  1. Correlation between FAPI expression and SUV in PET [1 year]

    Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining of pathological specimen

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:

  • adult patients (age>18 and<80 years)

  • patients with clinically suspected recurrent ovarian cancer

  • patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for the most proper treatment strategy within 1 week

  • patients who did not receive any other treatment 4 weeks before PET imaging

Exclusion Criteria:

  • pregnant patients

  • patients with poor performance status

  • patients unwilling to provide written informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai China 200127

Sponsors and Collaborators

  • RenJi Hospital

Investigators

  • Principal Investigator: Jianjun Liu, PH.D, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT05856409
Other Study ID Numbers:
  • LY2023-024-B
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by RenJi Hospital
68Ga-FAPI
PET
ovarian cancer
recurrence detection
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence

Study Results

No Results Posted as of May 12, 2023