68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.

September 19, 2024 updated by: Ruijin Hospital

68Ga-grazytracer PET/CT Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer: a Prospective, Observational Study.

Currently, there are limited methods available in clinical practice to distinguish pseudoprogression after immunotherapy. Most patients rely on follow-up observations to monitor the disease, which does not meet clinical needs. 68Ga-grazytracer is a novel imaging agent targeting granzyme B. By detecting the concentration of granzyme B, it reflects the localization of cytotoxic T cells in the tumor region and their potential ability to kill tumor cells. This study aims to leverage the simplicity, non-invasiveness, visualization, and semi-quantitative advantages of 68Ga-grazytracer PET imaging to evaluate its effectiveness and feasibility in diagnosing pseudoprogression.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patients are enrolled from Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine in China.

Description

Inclusion Criteria:

  1. Lung cancer patients who develope lesion enlargement and/or new lesions after treatment with immune checkpoint inhibitors;
  2. Pseudoprogression cannot be ruled out in clinical practice;
  3. Lung cancer confirmed by pathology or cytology, regardless of pathological type;
  4. Fully-informed written consent obtained from patients;
  5. Patient ability to comply with protocol requirements;
  6. Age 18-75 years;
  7. Life expectancy of at least 6 months.

Exclusion Criteria:

  1. Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
  2. Intestinal perforation, complete intestinal obstruction;
  3. Active phase of hepatitis B；
  4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;
  5. Patients with poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance 1
Time Frame: Follow-up for 4-8 weeks, not exceeding 12 weeks.
Sensitivity and specificity of 68Ga-grazytracer PET in diagnosing pseudoprogression
Follow-up for 4-8 weeks, not exceeding 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance 2
Time Frame: Follow-up for 4-8 weeks, not exceeding 12 weeks.
Investigating the optimal uptake value for 68Ga-grazytracer PET/CT imaging in diagnosing pseudoprogression.
Follow-up for 4-8 weeks, not exceeding 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-350

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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