Actively Recruiting

Phase Not Applicable
Age: 18Years - 88Years
All Genders
Healthy Volunteers
ID05034146

The Diagnostic Efficiency of 68Ga-FAPI PET/CT in Malignant Tumors

Led by Zhongnan Hospital · Updated on 2025-06-05

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the diagnostic potential of a new molecular imaging probe called gallium 68-labelled fibroblast-activation protein inhibitor (68Ga-FAPI) in detecting various malignant tumors. Fibroblast-activation protein (FAP) is commonly found in cancer-associated fibroblasts within tumor tissue and plays a role in tumor growth and spread. This study aims to confirm the advantages of 68Ga-FAPI over traditional imaging methods like 18F-fluorodeoxyglucose (18F-FDG) PET/CT, which can sometimes give false positive or negative results in certain cancers. Participants who have undergone whole-body 18F-FDG PET/CT scans for suspected or confirmed malignancies, particularly tumors with low FDG uptake such as glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases, will receive a whole-body 68Ga-FAPI PET/CT scan within one to four weeks. The 68Ga-FAPI is injected intravenously with a dose based on body weight, and imaging is performed 20 to 60 minutes after injection. This interventional study evaluates how well 68Ga-FAPI PET/CT can diagnose and stage malignant tumors. During the study, participants will undergo the 68Ga-FAPI PET/CT scan and be monitored for diagnostic sensitivity and specificity over three years. Researchers will also assess the prognostic value of FAPI PET parameters up to one year post-treatment, evaluate therapeutic response within one week after completion of therapy, and explore correlations between PET imaging and histopathological biomarkers within four weeks of the scan. The study includes informed consent and follow-up assessments to understand the imaging method's overall effectiveness in managing cancer.

CONDITIONS

Brief Title

68Ga-FAPI PET/CT in Malignant Tumors

Who Can Participate

Age: 18Years - 88Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Volunteers must agree to participate and sign an informed consent form
  • Patients with suspected or confirmed malignant tumors
  • Adults aged 18 to 88 years
  • All genders are eligible
Not Eligible

You will not qualify if you...

  • Female patients planning to become pregnant within 6 months
  • Pregnant or lactating women
  • Patients allergic to multiple drugs including the test drug
  • Participants in other clinical trials within the past one month

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants receive an intravenous injection of 68Ga-FAPI followed by a PET/CT scan to visualize tumor stroma and assess malignant tumors.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430071

Actively Recruiting

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Research Team

Y

Yong He, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Same-day dual-tracer PET/CT imaging with [68 Ga]Ga-FAPI-04 following [18F]FDG finds answers in patients presenting with negative or equivocal [18F]FDG.

Hongyan Li, Chongjiao Li, Yueli Tian...

https://pubmed.ncbi.nlm.nih.gov/40614035

Predictive value of [68Ga]Ga-FAPI-04 PET/CT on pathologic response to neoadjuvant chemoimmunotherapy for locally advanced resectable oral squamous cell carcinoma.

Yaqun Jiang, Zili Yu, Yanan Sun...

https://pubmed.ncbi.nlm.nih.gov/40548990

Dual-Time Point 68 Ga-FAPI-04 PET/CT Improves Tumor Delineation and Cervical Lymph Node Metastasis Identification in Patients With Head and Neck Squamous Cell Carcinoma.

Yaqun Jiang, Shuo Huang, Yueli Tian...

https://pubmed.ncbi.nlm.nih.gov/39668486