Predictive Value of PET/CT for Efficacy of Neoadjuvant Im... | NCT06895941

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

NCT06895941

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Status

Withdrawn

Last Update Posted

Apr 8, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Lung Cancer (NSCLC)
Neoadjuvant Immunotherapy

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to support implementation.

Expanded Access Info

Start Date

Apr 30, 2025Estimated

Primary Completion Date

Apr 1, 2027Estimated

Completion Date

Apr 1, 2027Estimated

First Submitted Date

Mar 20, 2025

First Submission Date that Met QC Criteria

Mar 20, 2025

First Posted Date

Mar 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 8, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chang Chen, Chief Physician, Shanghai Pulmonary Hospital, Shanghai, ChinaPrincipal Investigator

Lead Sponsor

Shanghai Pulmonary Hospital, Shanghai, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET	Diagnostic Test	Exploring the predictive value of PET/CT metabolic parameters for the efficacy of neoadjuvant immunotherapy in non-small cell lung cancer.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Non-small cell lung cancer patients receiving neoadjuvant immunotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai East Hospital		Shanghai	Shanghai Municipality	200433	China
Shanghai Pulmonary Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided