A Prospective Cohort Study of 68ga-FAPI-pet-ct Versus FDG-pet-ct for Ovarian Cancer

NCT ID: NCT05824247

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-06-01

Brief Summary

A study to discuss the advantage of Fapi PET- CT in the initial diagnosis staging and lesion determination of ovarian cancer,whether it can be a evaluation strategy as an R0 evaluation tool or a prediction tool of chemotherapy response and evaluation of prognosis.

Detailed Description

Ovarian cancer is a challenging disease. It is difficult to diagnose early, and the recurrence rate is high after initial treatment. In the past decades, in addition to cancer treatment methods, imaging evaluation has also made corresponding progress. In particular, molecular imaging using FDG-PET / CT has shown a strong role in ovarian cancer. It can locate metabolic changes before anatomical changes, point out small lymph node (LN) metastasis, find distant metastasis and definite recurrence.In terms of diagnosis, several studies have shown that PET-CT is superior to CT in ovarian cancer staging and has obvious advantages in the determination of extraperitoneal metastasis; In terms of predicting whether ro surgery can be performed, there are some mature scoring systems, such as eisenkop,suidan score etc.but there is still no unique scoring mode suitable for PET-CT; Despite the above advantages, the nonspecific uptake mechanism of FDG-PET may lead to false positive results.Cancer associated fibroblasts (CAFs) are one of the factors that independently mediate tumor growth and metastasis. They are also related to extracellular fibrous tissue and tumor size Fibroblast activation protein (FAP) is overexpressed in fibroblasts of many epithelial cancers, but rarely expressed in normal tissues.Therefore, imaging with FAP as a marker is a promising way in many tumor types In our previous study, [68Ga] GA dotafapi - PET / CT D compared with [18F] - FDG PET / CT has advantages in detecting primary and metastatic lesions of many tumors, especially peritoneal metastatic tumors, such as ovarian cancer.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

68Ga-FAPI-PET-CT

a new technology that using Fibroblast activation protein （FAP）inhibitor as the tracer of PET-CT

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with primary epithelial ovarian cancer confirmed by clinical consideration or puncture

2. PET-CT was chose as the initial imaging evaluation tool.

Exclusion Criteria

1. Patients with acute inflammation

2. Lacking of clinical data

3. Severe complications and PET-CT contraindications

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

JianFa Lan, Doctor

Role: CONTACT

407136123@qq.com

18810535017

Facility Contacts

Zhengyi Chen, doctor

Role: primary

407136123@qq.com

18810535290

Other Identifiers

XMYY-2019-XJS1130

Identifier Type: -

Identifier Source: org_study_id