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Adaptive Radiation Therapy for Cancer

Phase < 1

Recruiting

Led By Jill De Vis, MD, PhD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

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

Must have

Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions, minimum size 7mm) with CT scan, MRI, or calipers by clinical exam

ECOG performance status </=1 Karnofsky >/=70%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

Study Summary

This trial uses MRI to predict how tumors will respond to radiation treatment, helping doctors decide the best course of action.

Who is the study for?

This trial is for adults with certain head and neck cancers or brain tumors, who can be measured by scans, have a life expectancy over 6 months, and are in good physical condition. They must not be pregnant, agree to use birth control, and able to consent.Check my eligibility

What is being tested?

The study tests if new MRI methods combined with PET scans using a tracer called 18F-fluoromisonidazole can predict tumor resistance to radiation therapy due to low oxygen levels in the tumor.See study design

What are the potential side effects?

Possible side effects include reactions similar to those from compounds like the tracer used (18F-FMISO), which may involve allergic responses. The imaging procedures themselves are generally safe but may pose risks related to contrast agents or sedation.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor that can be measured with a scan or clinical exam.

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I am mostly able to care for myself and carry out daily activities.

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I have been diagnosed with head and neck cancer or a brain-related cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Validate non-invasive, MRI-based markers of tumor hypoxia in patients with brain metastases or head and neck cancer with and without evidence of tumor hypoxia identified by 18F-FMISO-PET-CT

Secondary outcome measures

Assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI

Other outcome measures

Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome

Trial Design

2Treatment groups

Experimental Treatment

Group I: Locally Advanced Squamous Cell Carcinoma of the Head and NeckExperimental Treatment3 Interventions

Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.

Group II: Brain metastasesExperimental Treatment3 Interventions

Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-fluoromisonidazole

2007

Completed Phase 2

~20

Magnetic Resonance Imaging (MRI)

2015

Completed Phase 4

~1800

Positron Emission Tomography (PET)

2018

Completed Phase 4

~1390

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,885 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,802 Total Patients Enrolled

Jill De Vis, MD, PhDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center

Media Library

Locally Advanced Squamous Cell Carcinoma of the Head and Neck Clinical Trial Eligibility Overview. Trial Name: NCT05996432 — Phase < 1

Locally Advanced Squamous Cell Carcinoma of the Head and Neck 2023 Treatment Timeline for Medical Study. Trial Name: NCT05996432 — Phase < 1

Brain Tumor Research Study Groups: Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Brain metastases

Brain Tumor Clinical Trial 2023: Locally Advanced Squamous Cell Carcinoma of the Head and Neck Highlights & Side Effects. Trial Name: NCT05996432 — Phase < 1

Frequently Asked Questions

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

What is the highest possible number of participants that can enroll in this clinical trial?

"Affirmative, the information on clinicaltrials.gov suggests that this research initiative is presently recruiting participants. This medical trial was published online on May 17th 2023 and updated most recently on August 10th of the same year. In total 48 patients will be accepted across a single site."

Answered by AI

Are enrollment opportunities available for this research endeavor?

"Yes, the information available on clinicaltrials.gov confirms that this medical trial is presently enrolling participants. Initially posted on May 17th 2023 and last updated August 10th of the same year, it seeks 48 individuals from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy

Jill De Vis 2023. "Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05996432.