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

Sponsor
The First Affiliated Hospital of Xiamen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05824247
Collaborator
(none)
60
1
38
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 68Ga-FAPI-PET-CT

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Cohort Study of 68ga-FAPI-pet-ct Versus FDG-pet-ct for Ovarian Cancer
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Outcome Measures

Primary Outcome Measures

  1. coincidence rate [1 year]

    The consistency between the lesions detected by PET CT and those detected during operation (based on pathology)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Xiamen University Xiamen Fujian China 361000

Sponsors and Collaborators

  • The First Affiliated Hospital of Xiamen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier:
NCT05824247
Other Study ID Numbers:
  • XMYY-2019-XJS1130
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The First Affiliated Hospital of Xiamen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023