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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

ConditionThyroid Gland Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperpolarized Carbon C 13 Pyruvate

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo hpMRI

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Arm I ( Health Volunteer MRI)Active comparator 1 intervention
Group B: Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods

To measure metabolic imaging data or information derived from hyperpolarized pyruvate MRI (hpMRI) that can be used to identify an early indication of response to therapy in patients with thyroid cancer. Specifically, we measure the kPL-the apparent rate constant for conversion of HP pyruvate into lactate-after one week of treatment compared to baseline measurements acquired prior to start of therapy. The kPL will be calculated from dynamic images of HP pyruvate and its metabolites. The kPL values will be calculated for each tumor and its adjacent tissue by a radiologist and physicist in conjunction using region of interest analysis to identify the margins of the tumor and surrounding normal tissue.

Time frame
1 year

Secondary outcomes

1

Early metabolic changes

To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy. The imaging biomarker for tumor metabolism, kPL, will be calculated from dynamic images of HP pyruvate and its metabolites.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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