Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral chemotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. William Chu
• Collaborator: Philips Medical Systems
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Able to give informed consent

• Weight <140kg

• Biopsy-proven recurrent rectal adenocarcinoma

• Assessed by the treating surgeon, medical oncologist and radiation oncologist, and following a multidisciplinary discussion, determined to have unresectable and/or inoperable disease in the presence or absence of distant metastases

• Assessed by the treating radiation oncologist and medical oncologist determined to be fit for reirradiation and chemotherapy

• Prior pelvic radiotherapy

• Target lesion visible by MR

• Target lesion accessible for MRg-FU procedure

• Target lesion maximum dimension ≤ 6cm

• Able to communicate sensation during MRg-FU treatment

Exclusion Criteria:

• Abdominal or pelvic surgery (excluding biopsy) ≤ 6 weeks prior to study enrolment

• Chemotherapy or other systemic anti-cancer agent ≤ 6 weeks prior to enrolment

• Previous radiotherapy ≤ 6 weeks prior to enrolment

• Recurrent tumour involves small bowel

• Unable to characterize pain

• Pregnant / Nursing woman

• Orthopaedic implant along proposed MRg-FU beam path or at site of target lesion.

• Serious cardiovascular, neurological, renal or hematological chronic disease

• Active infection

• Unable to tolerate required stationary position during treatment

• Allergy to MR contrast agent or sedation