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Radiation Therapy

Perfusion CT Imaging for Lung Cancer

N/A

Waitlist Available

Led By Christopher Lee, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

No concurrent chemotherapy

Biopsy proven non-small cell lung cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post sbrt

Awards & highlights

Study Summary

This trial is studying how well dynamic perfusion computed tomography works in patients with stage I-II non-small cell lung cancer that is not spread to other parts of the body.

Who is the study for?

This trial is for adults with stage I-II non-small cell lung cancer that hasn't spread, who haven't had radiation in the same area or concurrent chemotherapy. They must be able to lie still for scans and follow breath-holding instructions, not have allergies to iodinated contrast that can't be pre-medicated, and agree to use contraception if of child-bearing potential.Check my eligibility

What is being tested?

The study tests how blood flow in tumors changes using dynamic perfusion computed tomography (CT) imaging before, during, and after stereotactic body radiation therapy (SBRT). SBRT is a precise form of radiation treatment aimed at minimizing damage to healthy tissue.See study design

What are the potential side effects?

Potential side effects include those related to CT imaging such as reactions to contrast dye like itching or rash. SBRT may cause skin irritation at the treatment site, fatigue, shortness of breath, chest pain or coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently receiving chemotherapy.

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My lung cancer diagnosis was confirmed through a biopsy.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am a woman capable of becoming pregnant.

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I have not had radiation therapy on the same area before.

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My scans show no signs of cancer spread to lymph nodes.

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I am approved for and scheduled to receive SBRT treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post sbrt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months post sbrt

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post sbrt 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 blood flow (mL/min/100 g) as measured on perfusion CT

Change in blood volume (mL/100 g) as measured on perfusion CT

Change in mean transit time (seconds) as measured on perfusion CT

+1 more

Secondary outcome measures

Clinical tumor response assessed by CT scans as determined by Response Evaluation Criteria in Solid Tumors criteria version 1.1

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Anorexia

21%

Chest pain

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Otitis externa

Alopecia

Sinusitis

Dehydration

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Hypertension

Hypernatremia

Creatinine increased

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Blurred vision

Hearing impaired

Rash

Eye pain

Tachycardia

Lung infection

Neuropathy

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (DPCT)Experimental Treatment3 Interventions

Patients undergo DPCT at baseline, during SBRT (after 2 of 3 fractions or 3 of 5 fractions), and then at 1 and 3 months post stereotactic body radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography Perfusion Imaging

2016

Completed Phase 2

~90

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Society of Thoracic RadiologyUNKNOWN

1 Previous Clinical Trials

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,303 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,110 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03091816 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Diagnostic (DPCT)

Non-Small Cell Lung Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT03091816 — N/A

Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03091816 — N/A

Frequently Asked Questions

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

Is enrollment currently underway for this research project?

"Clinicaltrials.gov reveals that this trial, which went live on May 8th 2017 and was updated August 5th 2022, is currently not recruiting new patients. However, there are 4167 alternative medical studies actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dynamic Perfusion Computed Tomography in Patients With Localized Non-small Cell Lung Cancer

2017. "Dynamic Perfusion Computed Tomography in Patients With Localized Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03091816.

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