Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
ID04596670

68Ga-ICAM-1pep PET/CT Imaging of Tumor Responses to Radiotherapy in Cancer Patients

Led by Peking University Cancer Hospital & Institute · Updated on 2024-08-19

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

P

Peking University Cancer Hospital & Institute

Lead Sponsor

P

Peking University Health Science Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the use of a new imaging agent called 68Ga-ICAM-1pep in cancer patients undergoing radiotherapy. Researchers want to see if this agent can help predict the abscopal effect, a phenomenon where radiotherapy affects tumors outside the treated area. The study focuses on patients with various cancers such as lung, esophagus, and cervical cancer, and it is an early-phase clinical trial investigating this new approach. Participants will receive a single intravenous dose of 2.96 MBq/kg of 68Ga-ICAM-1pep. PET/CT scans will be performed about one hour after the injection. There are two groups: patients who have not yet received radiotherapy and those who have completed radiotherapy. Imaging will be done before and during radiotherapy to observe tumor responses. During the study, participants will undergo PET/CT scans covering from the head to the upper thigh. Researchers will measure the standardized uptake values (SUVs) of 68Ga-ICAM-1pep before treatment and monitor changes during radiotherapy, about 3 to 4 weeks after it begins. The study includes monitoring for compliance with imaging procedures and overall safety until the study ends in late 2025.

CONDITIONS

Brief Title

68Ga-ICAM-1pep PET/CT in Cancer Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • ECOG performance status score of 0 or 1
  • Suspected or confirmed lung cancer, esophagus cancer, cervical cancer, or other cancers recommended for PET/CT imaging by clinicians
Not Eligible

You will not qualify if you...

  • Pregnant or nursing
  • Severe liver or kidney dysfunction
  • Low white blood cell count (less than 3 x 10^9/L)
  • Inability to comply with PET/CT imaging procedures

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 undergo PET/CT imaging with the 68Ga-ICAM-1pep radiotracer before radiotherapy to assess tumor responses.

1 visit (in-person)

Treatment

Duration - 3 to 4 weeks

Participants receive radiotherapy as prescribed by their clinicians.

Diagnostic Evaluation

Duration - 1 day

Participants undergo PET/CT imaging with the 68Ga-ICAM-1pep radiotracer after radiotherapy to evaluate changes in tumor responses.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

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Research Team

T

Ting Zhang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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