Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06648317

Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions

Led by Peking University Cancer Hospital & Institute · Updated on 2024-11-25

20

Participants Needed

1

Research Sites

39 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the ability of [68Ga]N188, a radiolabelled probe targeting nectin-4, to detect overexpression of nectin-4 in patients with various lung lesions, including inflammation and lung cancer. This observational study aims to improve diagnostic imaging for these conditions by assessing the probe's uptake in affected lung tissue. Participants will undergo PET/CT imaging using the [68Ga]N188 probe to identify nectin-4 expression. Additionally, all participants will have an 18F-FDG PET/CT scan within one week as part of the study procedures. The study includes adults between 18 and 75 years old and includes measures to ensure participant safety and compliance. During the study, participants will be assessed through imaging scans and clinical follow-up to measure the standardized uptake value (SUV) of the probe over one year. Researchers will monitor heart function and other health parameters to ensure safety. Participants are expected to comply with follow-up visits and may undergo pregnancy testing and contraception use if applicable. The total study period includes initial imaging and long-term observation of imaging outcomes.

CONDITIONS

Brief Title

Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years, male or female
  • Normal heart function
  • Estimated survival of at least 12 weeks
  • Good compliance with follow-up visits
  • At least one measurable target lung lesion according to RECIST1.1 criteria
  • Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting
  • Fertile men and women must agree to use effective contraception during the study and for 3 months after
  • Patients recommended by clinicians for PET/CT for tumor diagnostic staging
  • Ability to understand and voluntarily consent to participate
Not Eligible

You will not qualify if you...

  • Serious abnormalities of liver, kidney, or blood function
  • Pregnant or breastfeeding women
  • Unable to lie flat for half an hour
  • Refusal to participate in the clinical trial
  • Claustrophobia or other mental health conditions
  • Any other condition deemed unsuitable by the researchers

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 1 week

Participants undergo PET/CT scans to evaluate lung lesions and detect nectin-4 overexpression.

1 visit (in-person)

Long-term Monitoring

Duration - 1 year

Participants are monitored for changes in standardized uptake value (SUV) over 1 year.

Follow-up visits as scheduled for up to 1 year

Trial Site Locations

Total: 1 location

1

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

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Research Team

N

Nan Li

X

Xin Zhou, MD

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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