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hpMRI Scan for Thyroid Cancer
Phase 1
Recruiting
Led By Stephen Y Lai
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial looks at whether a special kind of MRI scan can help doctors predict how well patients with thyroid cancer will respond to radiation therapy and/or systemic therapy before surgery.
Who is the study for?
This trial is for individuals with thyroid cancer or other head and neck malignancies who are undergoing radiation or systemic therapy before surgery. Participants must understand the study's experimental nature and give informed consent. It excludes those with severe claustrophobia, certain implants, cardiac arrhythmia, allergy to Gadavist contrast, eGFR < 30, or women who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial is testing if a special type of MRI scan using hyperpolarized carbon C 13 pyruvate (hpMRI) can predict how well patients respond to treatment for thyroid cancer and related conditions. The hpMRI may help in planning more effective treatments by providing early feedback on the success of ongoing therapies.See study design
What are the potential side effects?
Potential side effects from this investigational scan could include discomfort during the procedure due to its duration or position required. There might also be risks associated with allergic reactions to the imaging contrast agent used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods
Secondary outcome measures
Early metabolic changes
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)Experimental Treatment2 Interventions
Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate IV over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.
Group II: Arm I ( Health Volunteer MRI)Active Control1 Intervention
Healthy volunteers undergo MRI over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Hyperpolarized Carbon C 13 Pyruvate
2018
Completed Phase 1
~10
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,354 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,090 Total Patients Enrolled
Stephen Y LaiPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
1,043 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced strong fear in small, enclosed spaces in the past.You have implants that can be activated by electricity, magnets, or movement, which would prevent you from having a magnetic resonance imaging (MRI) scan.You have a history of abnormal heart rhythm.You are allergic to the Gadavist contrast used for IV injections.Your kidney function is very low, with an estimated glomerular filtration rate (eGFR) less than 30.You have been diagnosed with thyroid cancer or other cancers in the head and neck that need treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I ( Health Volunteer MRI)
- Group 2: Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)
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.
Thyroid Cancer Patient Testimony for trial: Trial Name: NCT04589624 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people is the trial currently accommodating?
"Affirmative. The clinical trial site states that this trail, which was initially posted on August 12th 2020, is actively enrolling participants. Forty-two individuals need to be enlisted from one medical facility."
Answered by AI
Are there any slots available to join this experiment?
"According to the information available on clinicaltrials.gov, this medical trial is still open for participants since its initial posting in August of 2020 and most recent amendment made in November 2022."
Answered by AI
How have Magnetic Resonance Imaging studies been utilized in other experimental research?
"Currently, 6 active trials on Magnetic Resonance Imaging are being conducted with two of those studies in their final phase. While some sites for the research reside in Houston, Texas, a total of 31 clinical trial locations across the country are investigating this area."
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
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have recently been diagnosed with nodules. I’m not sure if they are cancerous because I can’t get a biopsy scheduled. I know one of the nodules is in an area that is usually malignant. I’ve been trying for a week. I would like to help find other treatments than just the typical treatment for hyperthyroidism-thyroid blocker, radioactive iodine, and removal of thyroid.
PatientReceived no prior treatments
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