NCT04717804

Brief Summary

The researchers plan to investigate two ways of visualizing and planning to account for the respiratory motion which takes place while treating lung tumors with radiation therapy. The researchers will determine if a traditional snapshot (free-breathing) CT or a longer-lasting CT encompassing the breathing cycle better matches a patient's breathing during treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

August 17, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

January 11, 2021

Last Update Submit

June 25, 2024

Conditions

Cancer of Lung

Outcome Measures

Primary Outcomes (1)

  • To investigate radiation therapy treatment tumor localization accuracy by determining whether the FB or AIP images is more representative of the target at treatment.

    This will be quantitively determined by quantifying the agreement between the two CT scans using the Dice coefficient (DSC) as a metric for localization accuracy.

    2 weeks

Study Arms (2)

AIP (Average Intensity Projection) CT (Computed Tomagraphy)

ACTIVE COMPARATOR

An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.

Other: AIP CT

FB (Free-Breathing) CT

PLACEBO COMPARATOR

A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.

Other: FB (Free-Breathing) CT

Interventions

AIP CTOTHER

An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.

Also known as: CT Imaging
AIP (Average Intensity Projection) CT (Computed Tomagraphy)
FB (Free-Breathing) CTOTHER

A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.

Also known as: CT Imaging
FB (Free-Breathing) CT

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years.
  • Ability to provide informed written consent in either English or Spanish.
  • Patients with cancer or presumed cancer involving the lung (primary or secondary) planned to undergo lung SBRT technique or IMRT technique with an SBRT setup in 10 or fewer fractions.

You may not qualify if:

  • Current pregnancy, as this is a contraindication to receiving radiation therapy.
  • Patients to be treated to multiple targets concurrently.
  • Any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to the prescribed pattern of radiation therapy.
  • Poor lung function, as judged by the prescribing radiation oncologist, sufficiently limiting to make the patient not a candidate for 4D imaging (for example major differences between the 4D and free-breathing CT scan).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Postmortem Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AutopsyDiagnostic Techniques and ProceduresDiagnosisDiagnostic ImagingInvestigative Techniques

Study Officials

  • Daniel Saenz, PhD

    UT Health San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 22, 2021

Study Start

August 17, 2021

Primary Completion

November 14, 2023

Study Completion

November 14, 2023

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)