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NCT Number: NCT06614062

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Departments of Nuclear Medicine

Chengdu, Sichuan, 610072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Primary outcomes

  1. Correlation between clincal indicater and PET/CT results

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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