Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID05543954

A Pilot Study of 68Ga-FAPI-RGD PET/CT Imaging in Lung Cancer Patients

Led by Peking Union Medical College Hospital · Updated on 2024-07-05

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new dual-target imaging agent called 68Ga-FAPI-RGD for PET/CT scans in patients with lung cancer. This agent targets both fibroblast activating protein (FAP) on tumor tissues and integrin b1vb23 receptors on blood vessels, aiming to improve visualization of lung cancer lesions. The study compares this novel agent with conventional 18F-FDG and single-target agents 68Ga-FAPI and 68Ga-RGD to overcome limitations of current imaging methods. Participants will receive intravenous injections of the imaging agents, including 68Ga-FAPI-RGD, 18F-FDG, 68Ga-FAPI, and 68Ga-RGD, at doses based on body weight. Each patient undergoes PET/CT scans within two weeks after receiving 68Ga-FAPI-RGD and one of the other agents. Three experimental groups compare 68Ga-FAPI-RGD with either 18F-FDG, 68Ga-FAPI, or 68Ga-RGD to assess diagnostic performance. During the study, participants will have PET/CT scans and monitoring for diagnostic accuracy over about one year. Researchers will evaluate the imaging agents' uptake at different times and radiation dosimetry. The trial includes assessments of lung cancer lesions using these agents to understand their ability to detect tumors effectively. Participants' safety and study compliance are monitored throughout the trial period.

CONDITIONS

Brief Title

68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with confirmed or suspected lung cancer
  • Undergo 68Ga-FAPI-RGD and 18F-FDG (or 68Ga-FAPI or 68Ga-RGD) PET/CT scans within 2 weeks
  • Signed written consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Breastfeeding
  • Any medical condition that may significantly interfere with study compliance according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 - Within 2 weeks

Participants undergo PET/CT scans using 68Ga-FAPI-RGD combined with either 18F-FDG, 68Ga-FAPI, or 68Ga-RGD to assist in lung cancer diagnosis.

2 to 3 visits depending on imaging agents used

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored for diagnostic performance and dosimetry outcomes for up to 1 year following imaging.

Follow-up assessments as scheduled by the study team

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China

Actively Recruiting

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Research Team

Z

Zhaohui Zhu, MD,PHD

R

Rongxi Wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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