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NCT Number: NCT06232122

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

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

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chang-Gung Memorial Hospital, Linkou Branch

Taoyuan City, Taiwan

Location status: Recruiting

Location contact

Feng-Yuan Liu

CONTACT

[email protected]

(+886)975365782

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

68Ga-FAPi-46

Diagnostic Test

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

Other names: 68Ga-fibroblast activating protein inhibitors

18F-FDG

Diagnostic Test

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

Other names: 18F-fluorodeoxyglucose

Primary outcomes

  1. Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset

    Time frame: 2 months for individual participants to complete all visits

    Diagnostic performance is defined as the AUC value of ROC curve (sensitivity against 1-specificity at different PET/CT imaging scores ranged from 1 to 4).

    Cancer recurrence is defined by pathological or imaging evidence up to one year after 68Ga-FAPI-46 PET/CT study.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 5 years

    Progression-free survival (PFS) is defined as the duration (months) from the initiation of further therapy to disease progression assessed by Gynecological Cancer Intergroup (GCIG) guideline which incorporates both RECIST 1.1 and CA125 or to death.

  2. Overall Survival (OS)

    Time frame: 5 years

    Overall survival (OS) is defined as the duration (months) from the 68Ga-FAPI-46 PET/CT study to death.

Study contacts

Contact information is provided by the study sponsor or research team.

Feng-Yuan Liu

CONTACT

[email protected]

0975365782

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Evaluation of 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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2024
Registry last updated
Jan 30, 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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