NCT05609331

Brief Summary

To learn if using MRI (magnetic resonance imaging) to guide radiation therapy can help to control central lung cancer. The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2025

Completed
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

October 28, 2022

Last Update Submit

November 6, 2025

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

    through study completion, an average of 1 year

Study Arms (2)

Stage I-(Simulated Online Adaptive Planning)

EXPERIMENTAL

Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans.

Other: Simulated Online Adaptive Planning

Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)

EXPERIMENTAL

Participants will receive treatment with the investigational MRI-guided radiation therapy.

Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMART

Interventions

Simulated Online Adaptive PlanningOTHER

The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study

Stage I-(Simulated Online Adaptive Planning)
Stereotactic MRI-guided adaptive radiotherapy-SMARTRADIATION

The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study

Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)

Eligibility Criteria

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

You may qualify if:

  • Primary lung cancer or lung metastasis from another primary
  • Central tumors ≤ 2 cm from any mediastinal critical structure (proximal bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve
  • Age ≥ 18 years
  • Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

  • Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices
  • Inability to tolerate MR imaging (Ie. history of claustrophobia)
  • Women who are pregnant. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Stage 2:
  • Primary lung cancer or lung metastasis from another primary
  • Central tumors ≤ 2 cm from any mediastinal critical structure (proximal bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve
  • Age ≥ 18 years
  • Ability to understand and the willingness to sign a written informed consent
  • Determined by two thoracic radiation oncologists to require \> 10-15 fraction regimens if treated with CT-based, non-adaptive radiation therapy
  • Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices
  • Inability to tolerate MR imaging (Ie. history of claustrophobia)
  • Women who are pregnant. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Saumil Gandhi, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 8, 2022

Study Start

November 17, 2022

Primary Completion

November 5, 2025

Study Completion

November 5, 2025

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations

US(1)