NCT04589624 An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck Undergoing Radiation Therapy and/or Systemic Therapy
| NCT ID | NCT04589624 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Thyroid Gland Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2020-08-12 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2020-08-12 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.
Eligibility Criteria
Inclusion Criteria: * Be willing and able to provide informed consent * Be informed of the investigational nature of this study * Be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment Exclusion Criteria: * Have a history of severe claustrophobia * Have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (MRI) * Have a history of cardiac arrhythmia * Have an allergy to Gadavist intravenous contrast * Estimated glomerular filtration rate (eGFR) \< 30 * If female, be pregnant or breast feeding at time of consent
Contact & Investigator
Stephen Y Lai
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04589624 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Gland Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04589624 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04589624 currently recruiting?
Yes, NCT04589624 is actively recruiting participants. Contact the research team at sylai@mdanderson.org for enrollment information.
Where is the NCT04589624 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04589624 clinical trial?
NCT04589624 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Stephen Y Lai at M.D. Anderson Cancer Center. The trial plans to enroll 42 participants.