NCT02995889

Brief Summary

This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in patients with irradiated lung cancer in comparison with FDG-PET/CT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

4.3 years

First QC Date

December 9, 2016

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients with local and/or regional relapse

    6 months

Study Arms (1)

FLT-PET

EXPERIMENTAL
Device: FLT-PET

Interventions

FLT-PETDEVICE
FLT-PET

Eligibility Criteria

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

You may qualify if:

  • history with lung cancer, small cell or non-small cell
  • radiotherapy of lung cancer ended within the last 24 months
  • radiotherapy might be normofractionated or stereotactic
  • current suspicion of relapse
  • written and oral consent

You may not qualify if:

  • communication difficulties
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Dept. Respiratory Medicine, Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (2)

  • Christensen TN, Langer SW, Persson G, Larsen KR, Loft A, Amtoft AG, Berthelsen AK, Johannesen HH, Keller SH, Kjaer A, Fischer BM. 18F-FLT PET/CT Adds Value to 18F-FDG PET/CT for Diagnosing Relapse After Definitive Radiotherapy in Patients with Lung Cancer: Results of a Prospective Clinical Trial. J Nucl Med. 2021 May 10;62(5):628-635. doi: 10.2967/jnumed.120.247742. Epub 2020 Oct 9.

  • Christensen TN, Langer SW, Persson G, Larsen KR, Amtoft AG, Keller SH, Kjaer A, Fischer BM. Impact of [18F]FDG-PET and [18F]FLT-PET-Parameters in Patients with Suspected Relapse of Irradiated Lung Cancer. Diagnostics (Basel). 2021 Feb 11;11(2):279. doi: 10.3390/diagnostics11020279.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Andreas Kjær, MD phD MDSci

    Dept of Clinical Physiology, Nuclear medicine and PET, Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, research fellow

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 19, 2016

Study Start

November 1, 2014

Primary Completion

February 7, 2019

Study Completion

February 7, 2020

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations