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

Thyroid Gland Carcinoma Clinical Trial

Official title:

Pilot Study of Metabolic Guidance for Therapy in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589624
• Other study ID #: 2020-0482
• Secondary ID: NCI-2020-0584320
• Status: Recruiting
• Phase: Phase 1
• Start date: August 12, 2020
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Stephen Y Lai
• Phone: 713-792-6528
• Email: sylai[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE: I. To obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods in patients with thyroid tumors or other malignancies of the head and neck receiving radiation therapy (XRT) and/or systemic therapy (e.g., target therapy, checkpoint inhibitors). SECONDARY OBJECTIVE: I. To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy. OUTLINE: Participants are assigned to 1 of 2 arms. ARM I: Healthy volunteers undergo MRI over 30 minutes. ARM II: 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 intravenously (IV) over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician. After completion of study intervention, thyroid cancer and other malignancies of the head and neck patients are followed up at 1 day.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Gland Carcinoma
• Thyroid Neoplasms

Intervention

Drug:
• Hyperpolarized Carbon C 13 Pyruvate
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Magnetic Resonance Imaging
Undergo hpMRI

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year

External Links

•   MD Anderson Cancer Center