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

NCT04060927 | Active Not Recruiting DMC FDA Device

• 3 other identifiers: IRB0008138300036616LCI-LUN-SBRT-002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

NSCLC; Lung; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials

  approx. 2 weeks

• Local control of treated tumor(s)

  up to 24 months

• Overall Survival

  approx. 5 years

• Change from Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Score

  pre-SBRT and 1, 3, 6, and 12 months after the last treatment of SBRT

Other Outcomes (1)

• Incidence of Grade 2 or higher non-hematologic toxicities attributed to SBRT and fiducial implantation

  up to 12 months after the last treatment of SBRT

Study Arms (3)

Group 1

EXPERIMENTAL

Freebreathing SBRT with SGRT

Device: SGRT

Group 2

EXPERIMENTAL

Breath hold SBRT with SGRT

Device: SGRT

Group 3

EXPERIMENTAL

Breath hold SBRT with SGRT in combination with implanted fiducials

Device: SGRT

Interventions

SGRT DEVICE

Surface Guided Radiation Therapy

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent with HIPAA authorization for release of personal health information.
• 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.
• ECOG Performance Status of ≤ 2.
• 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.
• Subjects may be receiving systemic chemotherapy or other systemic agents prior to enrollment, but these agents must be stopped during SBRT treatments.
• 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).
• 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.
• As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study

You may not qualify if:

• Subjects meeting any of the criteria below may not participate in the study:
• 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.
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• John Heinzerling, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 19, 2019
• Study Start: September 25, 2019
• Primary Completion: October 18, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)