Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06688071

FAPI PET/CT in Various FAP-Related Disease Patients

Led by Tianjin Medical University · Updated on 2025-02-11

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Tianjin Medical University

Lead Sponsor

T

Tianjin Medical University General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the usefulness of 68Ga/18F-FAPI PET/CT scans for diagnosing primary and metastatic lesions in patients with various FAP-related diseases. This observational study evaluates how well this imaging method detects tumors by measuring uptake values and calculating diagnostic accuracy, including sensitivity and specificity. Participants receive a single intravenous injection of 68Ga/18F-FAPI followed by PET/CT imaging within a specified time frame. The study measures the maximum standardized uptake value (SUVmax) of lesions. This approach is used for either initial assessment or detection of recurrence in malignant tumors. During the study, researchers assess lesion uptake and diagnostic efficacy within 30 days. Patients undergo PET/CT imaging and provide informed consent. The study monitors diagnostic outcomes to determine how effectively 68Ga/18F-FAPI PET/CT identifies tumor lesions in FAP-related diseases. Participation involves one imaging procedure and follow-up assessments within a month.

CONDITIONS

Brief Title

FAPI PET/CT in Various FAP-Related Disease Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Patients with suspected, newly diagnosed, or previously treated malignant tumors
  • Patients scheduled for FAPI PET/CT scan
  • Ability to provide informed consent and assent according to ethics guidelines
Not Eligible

You will not qualify if you...

  • Patients with non-malignant lesions
  • Patients who are pregnant
  • Inability or unwillingness to provide written informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day

Participants receive a single intravenous injection of 68Ga/18F-FAPI and undergo PET/CT imaging for initial assessment or recurrence detection of FAP-related disease.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 30 days

Participants are monitored for up to 30 days to assess standardized uptake values and diagnostic efficacy of the PET/CT scan.

Follow-up assessments as needed

Trial Site Locations

Total: 1 location

1

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China, 300052

Actively Recruiting

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Research Team

H

Haonan Yu, MD

S

Shaobo Yao, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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