NCT06895941

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
11mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

March 20, 2025

Last Update Submit

April 4, 2025

Conditions

Lung Cancer (NSCLC)Neoadjuvant Immunotherapy

Outcome Measures

Primary Outcomes (1)

  • FAPI PET/CT predicts efficacy

    AUC predicted by FAPI PET/CT for neoadjuvant immunotherapy in lung cancer.

    2025.3.1-2027.3.1

Interventions

PETDIAGNOSTIC_TEST

Exploring the predictive value of PET/CT metabolic parameters for the efficacy of neoadjuvant immunotherapy in non-small cell lung cancer.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-small cell lung cancer patients receiving neoadjuvant immunotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 26, 2025

Study Start

April 30, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)