NCT02505685

Brief Summary

The purpose of this study is to evaluate the use of Dynamic PET/CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 18, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

July 2, 2015

Last Update Submit

November 17, 2016

Conditions

Lung Cancer

Keywords

LungCancerBiomarkersPET-CTEarly detection

Outcome Measures

Primary Outcomes (1)

  • Compare baseline PET-CT with PET-CT after 7-14 days.

    12 months

Secondary Outcomes (3)

  • Evaluate disease-free survival (DFS) in lung cancer by using dynamic PET-CT.

    12 months

  • Evaluate overall survival rate (OS) in lung cancer by using dynamic PET-CT.

    12 months

  • Measuring response to treatment by PET-CT.

    12 months

Study Arms (1)

Lung cancer

People that were diagnosed with advanced lung cancer.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced lung cancer patients (Stage 4)

You may qualify if:

  • Age \> 18 years.
  • Lung cancer, stage 4
  • Patients are planned to be treated by a systemic anti-cancer therapy.
  • A define lesion for imaging.
  • Able and willing to sign an informed consent form.
  • First line therapy or at least 6 weeks after previous line of therapy

You may not qualify if:

  • Pregnant or lactating women.
  • Anti cancer therapy within the last 6 weeks before enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Lung NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nir Peled, MD PhD FCCP

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 22, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2020

Last Updated

November 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

article will be released

Locations

IL(1)