NCT05736991

Brief Summary

The purpose of this study is to evaluate the performance of a PET/ CT-based deep learning signature for predicting the grade 3 tumors based on the novel grading system in clinical stage stage I lung adenocarcinoma based on a multicenter prospective cohort.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 7, 2023

Last Update Submit

February 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Area under the receiver operating characteristic curve

    Area under the receiver operating characteristic curve

    2022.11-2023.4

Secondary Outcomes (5)

  • Sensitivity

    2022.11-2023.4

  • Specificity

    2022.11-2023.4

  • Positive predictive value

    2022.11-2023.4

  • Negative predictive value

    2022.11-2023.4

  • Accuracy

    2022.11-2023.4

Interventions

Radiomics Signature Based on PET-CT for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinical Stage I Lung Adenocarcinoma

You may qualify if:

  • (1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) The maximum diameter of lesion less than 4 cm on CT scans; (3) The maximum short axis diameter of lymph nodes less than 1 cm on CT scan; (4) The SUVmax of hilar and mediastinal lymph nodes less than 2.5; (5) Pathological confirmation of primary lung adenocarcinoma; (5) Age ranging from 20-75 years; (6) Obtained written informed consent.

You may not qualify if:

  • (1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Mucinous adenocarcinomas; (5) Participants who have received neoadjuvant therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, China

RECRUITING

Ningbo HwaMei Hospital

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Study Design

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

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 21, 2023

Study Start

November 1, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations