Determining if a PET/MRI can predict complete response from chemoradiotherapy before surgery in patients with locally advanced rectal cancer

Overview

Información sobre este estudio

To determine whether PET/MRI can accurately predict complete pathologic response from neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Histologically confirmed primary adenocarcinoma, clinical Stage II disease (T3-4, N0) or Stage III disease (any T, N1-2)
  • No known distant metastatic disease at initial staging
  • Patients for whom the interdisciplinary treatment team has selected standard CRT followed by TME as the treatment plan
  • Pre-treatment staging MRI available
  • Blood sugar levels less than 200 mg/dl at the time of the exam
  • A negative pregnancy test is required for female subjects of child-bearing potential within 48 hours of F-18 FDG injection
  • Informed consent for dual modality PET/MRI without IV contrast material
  • Age greater than 18, male or female

Exclusion Criteria

  • No available initial staging MR exam.
  • Any contraindication for MRI, including pacemakers, aneurysm clips, cochlear implants, and certain spinal stimulation devices.
  • Subjects with a metallic prosthesis in the pelvis that may interfere with the MR and PET imaging.
  • Nonsurgical candidates.
  • Patients with uncontrolled diabetes.
  • Patients with known distant metastatic disease (M1) at the time of initial staging.
  • Patients with evidence of mucinous subtype of adenocarcinoma on biopsy and/or on initial staging MR exam.
  • Prior pelvic radiation.
  • Prior chemotherapy or surgery for rectal cancer.
  • Patients in whom neoadjuvant therapy is contraindicated.
  • Female subjects who are breast-feeding or with a positive pregnancy test.
  • Patients with a known history of claustrophobia.
  • Subjects unable to provide informed consent.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Shannon Sheedy, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
.
CLS-20304179

Mayo Clinic Footer