Pilot Study of SGRT Alone vs. SGRT With Fiducials for Breath Hold SBRT tx of the Lung

LCI-LUN-SBRT-002: Pilot Study of SGRT Alone vs. SGRT in Combination With Fiducials for Breath Hold SBRT Treatments of the Lung

This is a pilot study designed to to provide data and experience comparing two different techniques of breath hold SBRT treatments. The first technique will include SGRT, but with the assistance of implanted fiducials. Subjects will be treated with a breath hold technique utilizing SGRT, but will also be imaged during treatment with fiducial match. The second technique will utilize SGRT for breath hold treatments without the assistance of implanted fiducials/continuous imaging.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: SGRT

Detailed Description

The study's primary objective is estimate the incidence of SBRT and fiducial-related pulmonary toxicities for subjects treated with SBRT who have tumors that move ≥ 1 cm in 3 different cohorts: 1) free breathing with SGRT 2) breath hold utilizing SGRT only; 3) breath hold utilizing SGRT in combination with implanted fiducials. Secondary objectives also include Estimate reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials estimating local control for SBRT in subjects treated in the three different cohorts, estimating overall survival, and evaluating quality of life. A safety objective of estimating acute and long-term grade 2 or higher non-hematologic toxicities attributed to SBRT/fiducial implantation in subjects treated in the three different cohorts will also be explored.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Freebreathing SBRT with SGRT	Device: SGRT; Surface Guided Radiation Therapy
Experimental: Group 2; Breath hold SBRT with SGRT	Device: SGRT; Surface Guided Radiation Therapy
Experimental: Group 3; Breath hold SBRT with SGRT in combination with implanted fiducials	Device: SGRT; Surface Guided Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of SBRT and fiducial-related pulmonary toxicities as assessed by NCI CTCAE v.5.0	The outcome will be recorded as a binary variable determined for each subject indicating whether or not the subject had at least one grade 2 or higher pulmonary toxicity related to SBRT or implantation of fiducials.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials	This will be recorded as numerical values for each of the shift/rotational directions and the vector composites of the directional shifts at the time of verification imaging.	approx. 2 weeks
Local control of treated tumor(s)	The outcome will be measured as the duration of time from enrollment to progression of the subject's treated tumor(s)	up to 24 months
Overall Survival	This outcome will be measured as the duration of time from the date of enrollment to the study to the date of death from any cause.	approx. 5 years
Change from Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Score	The MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning. Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms.	pre-SBRT and 1, 3, 6, and 12 months after the last treatment of SBRT

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Grade 2 or higher non-hematologic toxicities attributed to SBRT and fiducial implantation	Incidence rates for acute and long-term adverse events of special interest, SAEs, and deaths from the time of initiation of SBRT until 12 months after the last treatment of SBRT will be summarized as counts and proportions.	up to 12 months after the last treatment of SBRT

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Atrium Health Levine Cancer Institute
• Investigators: Principal Investigator: John Heinzerling, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): October 18, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Lung; Radiation Therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: IRB00081383; 00036616 (Other Identifier: Advarra IRB); LCI-LUN-SBRT-002 (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No