Clincosm LogoSign in Get a demo

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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04654234
Collaborator
(none)
20
Enrollment
1
Location
24
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Total body PET/CT (uExplorer)

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Total-body PET/CT Imaging Using the uEXPLORER in Non-small Cell Lung Cancer Patients Treated by Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiotherapy
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Tumor standard uptake value (SUV) [From randomisation to 1 year after radiotherapy]

    The dynamic change of tumor SUV examined by total-body PET/CT (uExplorer)

Secondary Outcome Measures

  1. Normal tissue standard uptake value (SUV) [From randomisation to 1 year after radiotherapy]

    The dynamic change of tumor SUV examined by total-body PET/CT (uExplorer)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hui Liu Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hui Liu, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04654234
Other Study ID Numbers:
  • GASTO-1067
First Posted:
Dec 4, 2020
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Hui Liu, Clinical Professor, Sun Yat-sen University
Non-small Cell Lung Cancer
Total-body PET/CT
uEXPLORER
Nivolumab
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jan 28, 2021