Clinical trial · Interventional
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Magnetic resonance-guided focused ultrasound | Device | — | UNRESOLVED |
| Standard Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRg-FU
- description
- Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.
- interventionNames
- Device: Magnetic resonance-guided focused ultrasound
- Radiation: Standard Radiation
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Acute toxicities
- timeFrame
- 3 months
- description
- Gastrointestinal and genitourinary toxicities assessed as per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 after each MRg-FU treatment and 30, 60 and 90 days post-treatment.
Secondary outcomes (4)
- measure
- Late toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPeng J, Partanen A, Pichardo S, Staruch R, Perry K, McGuffin M, Huang Y, Chan KK, Wong S, Czarnota G, Hynynen K, Chu W. Mild hyperthermia with magnetic resonance- guided high intensity focused ultrasound combined with salvage chemoradiation for recurrent rectal cancer. Int J Hyperthermia. 2024;41(1):2365385. doi: 10.1080/02656736.2024.2365385. Epub 2024 Jun 19. PMID 38897584