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
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 1
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 42 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Arm I ( Health Volunteer MRI)
Healthy volunteers undergo MRI over 30 minutes.
Procedure: Magnetic Resonance Imaging
Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)
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.
Drug: Hyperpolarized Carbon C 13 Pyruvate · Procedure: Magnetic Resonance Imaging
Hyperpolarized Carbon C 13 Pyruvate DRUG
Given IV
Magnetic Resonance Imaging PROCEDURE
Undergo MRI
Magnetic Resonance Imaging PROCEDURE
Undergo hpMRI
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods
Plazo: 1 year
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.
Medidas secundarias
Early metabolic changes
Plazo: 1 year
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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
M D Anderson Cancer CenterHouston, Texas, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- M.D. Anderson Cancer Center
- Inicio del estudio
- 12 ago 2020 Real
- Finalización primaria
- 31 may 2027 Estimado
- Finalización del estudio
- 31 may 2027 Estimado
- Primera publicación
- 19 oct 2020 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Pilot Study of Metabolic Guidance for Therapy in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026
