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Stereotactic Body Radiation Therapy (SBRT) for Lung Cancer

Phase 1

Waitlist Available

Led By Kristin Higgins, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks from study start

Awards & highlights

Study Summary

This trial is testing how well PET works in planning radiation therapy for lung cancer. Using PET may help doctors to maximize the dose to the cancer and minimize the dose to normal tissues.

Eligible Conditions

Stage II Lung Cancer
Lung Cancer
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks from study start

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks from study start

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks from study start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes

Positron-Emission Tomography

Secondary outcome measures

Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes

Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593

21%

Anemia

18%

Neutropenia

15%

Hypoalbuminemia

15%

White blood cell decreased ( leukopenia)

15%

Diarrhea

12%

Liver Dysfunction

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

Study treatment Arm

Gem + Xeloda + SBRT

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (FDG-PET, SBRT)Experimental Treatment3 Interventions

Participants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludeoxyglucose F-18

2018

Completed Phase 2

~550

Positron Emission Tomography (PET)

2018

Completed Phase 4

~1390

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,560 Total Patients Enrolled

RefleXion MedicalIndustry Sponsor

3 Previous Clinical Trials

555 Total Patients Enrolled

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,554 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (SBRT) Clinical Trial Eligibility Overview. Trial Name: NCT03493789 — Phase 1

Lung Cancer Research Study Groups: Diagnostic (FDG-PET, SBRT)

Lung Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT03493789 — Phase 1

Stereotactic Body Radiation Therapy (SBRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03493789 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional research initiatives that have utilized Stereotactic Body Radiation Therapy (SBRT)?

"Currently, 22 SBRT studies are active with one having reached the third phase of trials. The majority of these experiments take place in Wuhan, Hubei; however, 48 study sites have been established across the globe to test Stereotactic Body Radiation Therapy (SBRT)."

Answered by AI

What is the enrollment size for this research initiative?

"This research trail is not calling for participants at this time. It was listed on April 13th 2018 and had its most recent update registered on March 2nd 2022. Should you be looking into other studies, there are presently 4162 clinical trials actively seeking patients with stage I non-small cell lung cancer ajcc v7 and 22 trails utilizing Stereotactic Body Radiation Therapy (SBRT) open to participation."

Answered by AI

Is Stereotactic Body Radiation Therapy (SBRT) a reliable procedure for patients?

"Data regarding Stereotactic Body Radiation Therapy (SBRT) is limited, so our team at Power gave the therapy a score of 1 on their safety scale."

Answered by AI

Are there any more openings for participants in this trial?

"The clinical trial at hand is not presently seeking enrolment, as it was last updated on March 2nd 2022. Nonetheless, there are 4162 studies actively recruiting patients with stage I non-small cell lung cancer AJCC v7 and 22 trials related to Stereotactic Body Radiation Therapy (SBRT) in progress."

Answered by AI

What uses does Stereotactic Body Radiation Therapy (SBRT) commonly have?

"Stereotactic Body Radiation Therapy (SBRT) can be used to address seizures and epileptic episodes, as well as conditions such as coronary artery disease (CAD), malignancies, and positron emission tomography."

Answered by AI

Recent research and studies

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

clinicaltrials.govStudy

Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy

Kristin Higgins 2018. "Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03493789.