Marker Guided Breathhold Radiotherapy in NSCLC

• Sponsor: Steen Riisgaard Mortensen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02447900
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 71
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with locally advanced non-small cell lung cancer (NSCLC)

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Device: BioXmark	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Proof of Concept Study Evaluating Safety and Performance of a Gel Marker (BioXmark) Used for Image Guidance in Deep Inspiration Breathhold Radiotherapy (DIBH IGRT) in Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment	Device: BioXmark

Outcome Measures

Primary Outcome Measures

1. Visibility of the injected gel marker during the course of radiotherapy delivery [3 months]

   Stability of the geometrical configuration and visibility of the injected gel marker in 2D kV x-rays and CBCT (cone-beam computed tomography) acquired throughout the treatment course and quantified by vectors and contrast to noise ratio (CNR)

2. Number of pneumothoraxes in relation to placement procedure of the gel [0-1 week after placement of gel]

   Counting number of pneumothoraxes caused in relation to the placement procedure of the gel

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

• Age > 18 years old

• Histologically confirmed non-small cell lung cancer (NSCLC)

• Stage T1-4N1-3M0

• Performance status ≤ 2

• Inoperable

• FEV1 ≥ 1 l

• Ability to hold deep inspiration breathhold for > 15 seconds

• Accepting treatment at Rigshospitalet

• Eligible for concomitant chemo-radiotherapy

• If a woman is of childbearing potential, a negative pregnancy test must be documented

• Ability to understand the given information

• Signed written consent for inclusion into the study

Exclusion criteria

• Prior thoracic radiotherapy

• Allergy to Iodine or iodine based contrast

• In the opinion of the investigator, the patient will not be able to follow the study procedures or is considered not eligible for other reasons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet, Denmark	Copenhagen		Denmark

Sponsors and Collaborators

• Steen Riisgaard Mortensen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steen Riisgaard Mortensen, MD, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT02447900
• Other Study ID Numbers: 310-01
• First Posted: May 19, 2015
• Last Update Posted: Jan 29, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jan 29, 2021