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Trial Title:
A Prospective Cohort Study of 68ga-FAPI-pet-ct Versus FDG-pet-ct for Ovarian Cancer
NCT ID:
NCT05824247
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
Ovarian cancer
FAPI
PET-CT
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
68Ga-FAPI-PET-CT
Description:
a new technology that using Fibroblast activation protein （FAP）inhibitor as the tracer of
PET-CT
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.
Criteria for eligibility:
Study pop:
Patients with primary epithelial ovarian cancer confirmed by clinical consideration or
puncture
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
20 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengyi Chen, doctor
Phone:
18810535290
Email:
407136123@qq.com
Start date:
April 1, 2022
Completion date:
June 1, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05824247
