Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer

NCT ID: NCT06232122

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2028-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

68Ga-FAPI ,PET/CT

Inject 68Ga-FAPI and then perform PET/CT scan.

Group Type EXPERIMENTAL

68Ga-FAPI-46

Intervention Type DIAGNOSTIC_TEST

Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46

18F-FDG

Intervention Type DIAGNOSTIC_TEST

Intravenous injection of one dosage of 5-10mCi 18F-FDG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga-FAPI-46

Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46

Intervention Type DIAGNOSTIC_TEST

18F-FDG

Intravenous injection of one dosage of 5-10mCi 18F-FDG

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

68Ga-fibroblast activating protein inhibitors 18F-fluorodeoxyglucose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pathologically proven ovarian cancer with complete response after therapy
* Age between 30 and 80
* Elevation of serum CA125 value above the normal range (\>35 U/mL) or doubling of serum CA125 value within the normal range
* ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed
* Willing to enter this prospective study with signed informed consent form

Exclusion Criteria

* Patients with history of other malignancy
* Patients who are pregnant or lactating
* Patients with fasting fingerstick glucose level higher than 200 mg/dl
* Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies
* Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Feng-Yuan Liu, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang-Gung Memorial Hospital, Linkou Branch

Taoyuan, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Feng-Yuan Liu

Role: CONTACT

0975365782

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Feng-Yuan Liu

Role: primary

(+886)975365782

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202102208A0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.