Total-body PET/CT Imaging Using the uEXPLORER in Non-small Cell Lung Cancer Patients Treated by Induction Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiotherapy

January 21, 2024 updated by: Hui Liu, Sun Yat-sen University
The prospective study aims to explore the value of total-body PET/CT dynamic imaging (uExplorer) in assessing tumor metabolic heterogeneity and predicting prognosis for patients with locally advanced, unresectable non-small cell lung cancer (stage III) treated by neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Hui Liu

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Locally advanced non-small cell lung cancer patients treated by neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy

Description

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedures;
  • Patients aged 18~75 years old;
  • had histologically or cytologically confirmed non-small cell lung cancer;
  • Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy;
  • Life expectancy ≥12 weeks;
  • World Health Organization (WHO) Performance Status of 0 or 1;
  • had unresectable stage III disease according to the 8th edition of the American Joint Committee on Cancer staging system;
  • Women should be non-breast feeding during the study period;
  • Women of reproductive age (WOCBP) must agree to comply with the contraceptive method during the study treatment and for a period of 5 months following the last administration of the study treatment;
  • Men who have sex with WOCBP must agree to comply with the contraceptive method during the study treatment and for 7 months after the last administration of the study treatment;
  • Absolute neutrophil count ≥1500/uL, hemoglobin ≥9.0mg/dL, platelet ≥100000/uL;
  • Serum creatinine clearance >50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976);
  • Serum bilirubin ≤1.5 x upper limit of normal (ULN), Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN;
  • Forced expiratory volume in 1 second (FEV1) ≥800ml;

Exclusion Criteria:

  • Concurrent enrollment in another clinical study, unless it is an observational(non-interventional) clinical study;
  • Mixed small cell and non-small cell lung cancer histology;
  • Prior exposure to any anti-programmed cell death protein(PD)-1 or anti- PD-L1 antibody;
  • Active or prior documented autoimmune disease within the past 2 years;
  • Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
  • History of primary immunodeficiency;
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses;
  • History of another primary malignancy within 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
  • Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control;
  • Any situation not suitable for this study judged by researchers;

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total-body PET/CT (uExplorer)
Patients with locally advanced NSCLC will receive total-body PET/CT (uExplorer) scans before, during and after the treatment
Device: Total body PET/CT (uExplorer)
A total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER) with a 192-cm scan range was applied for cancer diagnosis, organ function assessment and treatment outcome prediction. The total-body PET scanner can acquire scans with lower administered activity or short acquisition time, total-body dynamic acquisition at a longer delayed time point, and high detectability of exiguous changes of the whole body, and tumor as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patlak-Ki (Ki)
Time Frame: From enrollment to 1 year after radiotherapy
The prognostic role of Patlak-Ki and its dynamic change during treatment
From enrollment to 1 year after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
standardized uptake value (SUV)
Time Frame: From enrollment to 1 year after radiotherapy
The prognostic role of SUV and its dynamic change during treatment
From enrollment to 1 year after radiotherapy
metabolic tumor volume (MTV)
Time Frame: From enrollment to 1 year after radiotherapy
The prognostic role of MTV and its dynamic change during treatment
From enrollment to 1 year after radiotherapy
total lesion glycolysis (TLG)
Time Frame: From enrollment to 1 year after radiotherapy
The prognostic role of TLG and its dynamic change during treatment
From enrollment to 1 year after radiotherapy

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hui Liu, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2020

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

November 28, 2020

First Submitted That Met QC Criteria

November 28, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-1067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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