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Lung cancer radiation study tests simpler breath hold method

NCT ID NCT04060927

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study looks at two methods for keeping the lungs still during radiation treatment for lung cancer. One method uses a special camera system (SGRT) alone, and the other adds small implanted markers (fiducials) for extra guidance. The goal is to see which approach is more reliable and causes fewer side effects. About 45 adults with early-stage lung cancer are taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

45 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Subject must meet all of the following applicable inclusion criteria to participate in this study: 1. Written informed consent with HIPAA authorization for release of personal health information. 2. Age ≥18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of fiducials in combination with SBRT in subjects \<18 years of age, children are excluded from this study. 3. ECOG Performance Status of ≤ 2. 4. Stage IA-IIB (T1a-T3bN0) presumed non-small cell lung cancer, carcinoid tumors, or lung metastasis that have ≥ 1 cm of respiratory associated motion measured on 4DCT at time of simulation for SBRT with or without respiratory motion suppression techniques. Histologic confirmation of malignancy is encouraged but not required. Primary or metastatic tumor ≤ 7 cm. 5. Subjects may be receiving systemic chemotherapy or other systemic agents prior to enrollment, but these agents must be stopped during SBRT treatments. 6. Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 14 days prior to day 1 of treatment. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause). 7. The effects of radiation on the developing human fetus are not well described. For this reason, women of child-bearing potential and non-sterilized men who are sexually active with a woman of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the time of informed consent until 5 days after last dose of SBRT. Contraceptive methods with low user dependency are preferable but not required. 8. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study Exclusion Criteria Subjects meeting any of the criteria below may not participate in the study: 1. Prior radiation to the chest that would overlap with the current radiation fields and determined by the treating physician to impede the treatment of the study malignancy. 2. Active ongoing pulmonary infection or pneumonitis that is requiring active treatment with antibiotics or steroids. Prior pneumonitis from drug or other therapies that has been treated within 15 days of first day of treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

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