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

NCT ID: NCT05856409

Last Updated: 2023-08-16

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

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-10

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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68Ga-FAPI Ovarian Cancer Epithelial Ovarian Cancer Positron Emission Tomography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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68Ga-FAPI

\[68Ga\]-FAPI is tumor imaging agent for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianjun Liu, PH.D

Role: PRINCIPAL_INVESTIGATOR

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tingting Wang, PH.D

Role: CONTACT

15000091930

Facility Contacts

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Jianjun Liu, PH.D

Role: primary

+86 13301826638

Other Identifiers

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LY2023-024-B

Identifier Type: -

Identifier Source: org_study_id

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