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ObservationalNCT06614062

Clinical Study of 18F-FAPI-RGD in Ovarian Cancer

An observational study of Observational, run by Sichuan Provincial People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in ovarian cancer. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination and compare it with 18F-FDG PET/CT imaging. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Observational
How many people
30 participants
Where
1 siteChina
Study dates
1 Dec 2023to 30 Aug 2024
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with diagnosed or highly suspected Ovarian cancer

Inclusion Criteria:• Age 18 and above• Patients who have been diagnosed with, or are clinically highly suspected of, Ovarian cancer and have had no other treatment within 3 months -

Exclusion Criteria:• Patients with a second primary tumor• Pregnant or breastfeeding• Severe liver or kidney disease•Claustrophobia or other PET/CT scan contraindications

-

Trial locations and contacts

1 site in 1 country.

China1 site
  • Departments of Nuclear Medicine

    Chengdu, Sichuan, 610072

Other trials in China

About this study

Official title: Clinical Study of 18F Labeled Probe Targeting Fibroblast Activation Protein Inhibitor and Integrin Avβ3 (FAPI-RGD) in Ovarian Cancer,comparison with 18F-FDG

The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in ovarian cancer. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination and compare it with 18F-FDG PET/CT imaging.

Read the detailed description

Ovarian cancer is the malignant tumor with the highest mortality rate among women, and also the most intractable gynecological malignant tumor in clinical treatment. Its incidence rate and mortality are increasing year by year. China's incidence rate of ovarian cancer ranks first in the world.Due to the lack of typical clinical symptoms and effective screening tools in the early stage, more than 70% of patients were in advanced cancer when diagnosed,that is, there was peritoneal and/or distant metastasis. The mortality rate was high (mortality/incidence rate ratio was 60%) , the radical cure rate was low, and the 5-year overall survival rate was only 30% . The survival rate of ovarian cancer is closely related to staging (stage I 5-year survival rate is 92%, stage IV is 5%) . Therefore, early and accurate detection and staging are of great significance for the selection of treatment methods and the improvement of patient survival rate.Positron emission tomography (PET) is a non-invasive molecular imaging technique. Currently, 18F-FDG PET/CT has been included as a routine examination in the postoperative evaluation of the NCCN ovarian cancer diagnosis and treatment guidelines as a supplementary examination method for preoperative evaluation. Therefore, 18F-FDG PET/CT is recommended by NCCN as an imaging biomarker for ovarian cancer, and performs well in early diagnosis, treatment planning, and postoperative evaluation. However, FDG PET/CT also has some limitations, such as its sensitivity being influenced by different histological subtypes (such as ovarian mucinous carcinoma, clear cell carcinoma, or low-grade serous carcinoma). In addition, false negatives caused by physiological high uptake in the intestine and false positives caused by ovarian physiological uptake and some benign lesions (such as cystadenoma, endometrioma, and acute inflammatory processes) still exist. Therefore, a more effective imaging technique is needed to improve the detection and staging of ovarian tumors.

α V β 3-Integrins play a crucial role in promoting and maintaining angiogenesis, and have been identified as biomarkers of angiogenesis. Research has found that integrins α V β 3 is highly expressed in neovascular endothelial cells and tumor cells, including ovarian cancer, and plays an important role in regulating tumor growth, angiogenesis, local invasion, and metastasis potential.Research has shown that 68 Ga-FAPI-04 is a novel radioligand targeting fibroblast activating protein (FAP), which has recently been used for tumor microenvironment imaging, especially cancer associated fibroblasts (CAFs), with promising imaging results . Research has shown that compared to 18F-FDG, 68Ga-FAPI PET/CT has higher sensitivity in detecting and diagnosing lymph node and peritoneal metastases in ovarian cancer.

Conditions
Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between clincal indicater and PET/CT results

    Correlation of ultrasound, CT, tumor markers and 18F-FAPI-RGD PET/CT results。

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start1 Dec 2023
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06614062
Sponsor's protocol ID
SichuanPPH-Ovarian cancer
Status last verified
Sep 2024
First submitted
23 Sep 2024
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Observational, run by Sichuan Provincial People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between clincal indicater and PET/CT results (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

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