NCT05824247

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

April 3, 2023

Last Update Submit

April 19, 2023

Conditions

Ovarian Cancer

Keywords

Ovarian cancerFAPIPET-CT

Outcome Measures

Primary Outcomes (1)

  • coincidence rate

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

    1 year

Interventions

68Ga-FAPI-PET-CTDEVICE

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

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with primary epithelial ovarian cancer confirmed by clinical consideration or puncture
  • PET-CT was chose as the initial imaging evaluation tool.

You may not qualify if:

  • Patients with acute inflammation
  • Lacking of clinical data
  • Severe complications and PET-CT contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

JianFa Lan, Doctor

CONTACT

18810535017407136123@qq.com

Study Design

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

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 21, 2023

Study Start

April 1, 2022

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

April 21, 2023

Record last verified: 2022-04

Locations

CN(1)