Predictive Value of PET/CT for Efficacy of Neoadjuvant Immunotherapy in Non-small Cell Lung Cancer

April 4, 2025 updated by: Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
The aim of this study was to investigate the enhancement of FAPI PET/CT metabolic parameters in predicting the efficacy performance of neoadjuvant immunotherapy using the pCR status of surgically resected specimens of lung cancer as the gold standard.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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, 200433
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai, China, 200433
        • Shanghai East Hospital

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

Non-small cell lung cancer patients receiving neoadjuvant immunotherapy

Description

Inclusion Criteria:(1) aged 18 years or older; (2) pathological diagnosis of non-small cell lung cancer; (3) lesions resectable by surgery; (4) no EGFR mutation or ALK mutation; (5) eligible for indications of neoadjuvant immunotherapy for lung cancer.

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Exclusion Criteria:(1) patients who had used any other antitumor drugs or radiotherapy; (2) comorbidities with other malignant neoplastic diseases or severe cardiovascular diseases; (3) uncontrollable diabetes mellitus or fasting blood glucose level higher than 11 mmol/L on the test day; (4) pregnancy or recent pregnancy plan; (5) distant metastasis.

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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
FAPI PET/CT predicts efficacy
Time Frame: 2025.3.1-2027.3.1
AUC predicted by FAPI PET/CT for neoadjuvant immunotherapy in lung cancer.
2025.3.1-2027.3.1

Collaborators and Investigators

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

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Collaborators

Shanghai East 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 (Estimated)

April 30, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETici

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

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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