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

NCT05856409 | Unknown

• 1 other identifier: LY2023-024-B
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

68Ga-FAPI; PET; ovarian cancer; recurrence detection

Outcome Measures

Primary Outcomes (3)

• Diagnostic Performance

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

  1 year

• Maximum standardized uptake value（SUVmax）

  Measurement of the maximum standardized uptake value of the lesion

  1 year

• Tumor-to-background ratio (TBR)

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

  1 year

Secondary Outcomes (1)

• Correlation between FAPI expression and SUV in PET

  1 year

Interventions

68Ga-FAPI DIAGNOSTIC_TEST

\[68Ga\]-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)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A prospective cohort of patients with clinically suspected recurrent ovarian cancer were enrolled, who underwent paired 68Ga-FAPI and 18F-FDG PET/CT.

You may qualify if:

• 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

You may not qualify if:

• pregnant patients
• patients with poor performance status
• patients unwilling to provide written informed consent

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical or biopsy tumor tissue specimens

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jianjun Liu, PH.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Wang, PH.D

CONTACT

15000091930; wangtt_shca@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 12, 2023
• Study Start: May 10, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 31, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)