NCT02273271

Brief Summary

The purpose of the study is to qualify, independently, tumor cell proliferation by 3'-Deoxy-3'-\[18F\]Fluorothymidine (FLT) -Positron Emission Tomography , and cell death by Diffusion Weighted Imaging (DWI) -Magnetic Resonance Imaging (MRI) compared to pathological quantification (% of viable tumor cells) of the primary tumor after pre-operative chemotherapy in patients with operable Non Small Cell Lung Cancer (NSCLC).

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
2 countries

2 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

First Submitted

Initial submission to the registry

October 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

October 16, 2014

Last Update Submit

October 29, 2015

Conditions

Non-small Cell Lung Carcinoma

Keywords

FLT-PETDWI-MRI

Outcome Measures

Primary Outcomes (3)

  • Percentage of Apparent Diffusion Coefficient (ADC) change

    Percentage of Apparent Diffusion Coefficient (ADC) change at day 14 relative to baseline

    day 14 relative to baseline

  • Percentage of FLT uptake change

    Percentage of FLT uptake change at day 14 relative to baseline

    day 14 relative to baseline

  • Pathological quantification (% viable residual tumor cells)

    participants will receive chemotherapy for up to 12 weeks (4 cycles) and followed by surgery (with an expected surgical preparation of 2-4 weeks)

    in average at week 16 from baseline

Secondary Outcomes (5)

  • Pre-operative (post-treatment) ADC measurement

    in average at week 15 from baseline

  • Pre-operative (post-treatment) FLT uptake measurement

    in average at week 15 from baseline

  • Tumor volume (baseline, day 14 and post-treatment)

    baseline, day 14 and post-treatment

  • Immunohistochemistry (IHC) cell proliferation marker Ki-67

    1y

  • Metabolic change from FDG-PET (if available)

    in average at week 9 from baseline

Study Arms (1)

Imaging arm

EXPERIMENTAL

18F-FLT-PET/CT and DWI-MRI scans at baseline, at 14 days after first administration of chemotherapy and after up to 4 cycles of chemotherapy

Other: 18F-FLT-PET/CT and DWI-MRI

Interventions

18F-FLT-PET/CT and DWI-MRIOTHER

Patients with NSCLC will undergo 18F-FLT-PET/CT and DWI-MRI scans on three separate occasions. Dedicated in-house developed software will be used to quantify 18F-FLT SUV and ADC to assess tumor characteristics and response to therapy.

Imaging arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • WHO performance status 0-1 (Appendix C)
  • Histologically or cytological confirmed clinical stage II-IIIA non-small cell lung carcinoma (NSCLC), according to 7th TNM classification (Appendix D) (NOTE: patients with resectable N2 disease are also eligible)
  • Baseline standard imaging assessment \& staging should be performed within 6 weeks prior to planned treatment start.
  • Patients must be candidate for curative intent surgery, and must be expected to complete the treatment.
  • ♦♦ Adequate hematology and biochemical investigations, (should be done maximum 6 weeks before treatment starts)
  • Normal bone marrow function based on routine blood samples, i.e. neutrophils ≥ 1.5 x 109/L, platelets ≥ 75 x 109/L, hemoglobin ≥ 10.0 g/dL
  • Normal kidney function creatinine clearance ≥ 60 mL/min,
  • Normal liver function assessed by routine laboratory examinations, i.e. bilirubin \< 1.5 x upper limit of normal (ULN), ALT\< 3 x ULN
  • Patients must not have any contraindication for 18F-FLT-PET/CT or MRI procedures.
  • Patient primary lung tumor larger than 20 mm in diameter (measured by diagnostic CT or MRI).
  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test before trial registration.
  • Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study procedure. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
  • Female subjects who are breast feeding should discontinue nursing before trial registration.
  • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

You may not qualify if:

  • Prior or current anticancer treatment for NSCLC, pre-operative therapy will include only chemotherapeutic drugs (pemetrexed is contraindicated), no other biological, targeted or radiotherapy is allowed
  • Treatment with any investigational drug substance within 4 weeks prior to registration.
  • Other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin
  • Evidence of any medical condition which would impair the ability of the patient to participate in the trial or might preclude therapy with chemotherapeutic drugs according to routine medical practice (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, known dihydropyrimidine dehydrogenase deficiency, active infection, uncontrolled diabetes mellitus; uncontrolled arterial hypertension, history of unstable myocardial infarction)
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istituto Clinico Humanitas

Milan, 20089, Italy

RECRUITING

Royal Marsden Hospital - Sutton, Surrey

Sutton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nandita deSouza

    Royal Marsden Hospital - Sutton, Surrey

    PRINCIPAL INVESTIGATOR

  • Sanjay Popat

    Royal Marsden Hospital - Chelsea, London

    STUDY CHAIR

Central Study Contacts

Oussama Karroum

CONTACT

003227741523oussama.karroum@eortc.be

Leslie Herman

CONTACT

003227741511leslie.herman@eortc.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2014

First Posted

October 23, 2014

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

GB(1)IT(1)