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MRI and Biomarker Monitoring for Head and Neck Cancer
N/A
Waitlist Available
Led By Clifton D Fuller
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
For females of child-bearing age, a negative pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years
Awards & highlights
Study Summary
This trial is looking at whether adding extra MRIs and blood tests can help researchers learn how a patient's tumor may change during radiation therapy.
Who is the study for?
This trial is for adults with certain head and neck cancers who haven't had distant metastases or previous radiation treatments in the affected area. They should be fit enough for curative radiotherapy, not pregnant, and able to undergo MRI scans without contraindications like metal implants or severe kidney issues.Check my eligibility
What is being tested?
Researchers are testing if additional MRIs and blood biomarker analysis can predict tumor changes during radiation therapy. Participants will have extra scans and blood tests beyond standard care to see if these methods improve understanding of treatment response.See study design
What are the potential side effects?
There may be minimal side effects related to MRI procedures such as discomfort from lying still. Blood draws might cause bruising or infection at the puncture site. Gadolinium contrast used in MRIs could pose risks for those with kidney problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am of child-bearing age and my pregnancy test is negative.
Select...
My cancer has not spread to distant parts of my body.
Select...
I have been diagnosed with squamous cell carcinoma in the head or neck.
Select...
I am scheduled for radiotherapy aimed at curing my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years
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 Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT)
Change in TK
Tumor growth velocity (TGV)
Secondary outcome measures
Locoregional control
Side effects data
From 2022 Phase 3 trial • 53 Patients • NCT0003329319%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
11600-Alanine aminotransferase increased
8%
16800-Bladder infection
8%
44800-Infections and infestations - Other specify
8%
58700-Nystagmus
4%
15000-Aspartate aminotransferase increased
4%
88500-White blood cell decreased
4%
15300-Ataxia
4%
33900-Fever
4%
25700-Diarrhea
4%
43100-Hypokalemia
4%
69700-Rash maculo-papular(targeted toxicity)
4%
13200-Anemia
4%
33300-Febrile neutropenia
4%
57600-Nausea(targeted toxicity)
4%
20500-Catheter related infection
4%
58300-Neutrophil count decreased
4%
41300-Hypercalcemia
4%
41400-Hyperglycemia(targeted toxicity)
4%
41600-Hyperkalemia
4%
42600-Hypoalbuminemia
4%
42700-Hypocalcemia
4%
64400-Personality change
4%
41500-Hyperhidrosis
4%
13500-Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (MRI, blood sample collection)Experimental Treatment4 Interventions
Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1920
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,349 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,546 Total Patients Enrolled
Clifton D FullerPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
53 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (MRI, blood sample collection)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project still have room for additional participants?
"Per the details on clinicaltrials.gov, this particular trial is not actively enrolling participants at present. The study was initially posted on May 18th 2017 and most recently updated on 11th of May 2022. However, 1685 other trials are presently accepting patients for participation."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I try to give back by doing medical studies to help people survive.
PatientReceived 2+ prior treatments
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