Clinical trial · Interventional
MRG FU With Radiotherapy for Palliation of H&N Cancer
Magnetic Resonance-Guided Focused Ultrasound Combined With Radiotherapy for Palliation of Head and Neck Cancer - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): On hold pending amendment approval
Summary
Brief summary (as posted)
Head and neck cancer is the sixth most common form of malignancy world-wide. Surgery, chemotherapy and radiation are associated with a high burden of side effects; tumour recurrence within the neck continues to be a major cause of treatment failure. To our knowledge, this research is the first clinical study in human subjects to utilize magnetic resonance guided focused ultrasound to treat cancer of the neck. The goal is to evaluate the safety and technical feasibility of this therapy in order to guide future clinical applications such as ablation, radiosensitization or drug delivery that could ultimately improve clinical outcomes. A total of 10 patients will be treated with MR guided focused ultrasound.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR Guided Focused Ultrasound | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR Guided Focused Ultrasound
- interventionNames
- Other: MR Guided Focused Ultrasound
Primary outcomes (2)
- measure
- Safety and Toxicity Assessment of MRg-FU Treatment to the Head and Neck Region.
- timeFrame
- 90 days
- description
- The number, type and severity of adverse effects as assessed using NCI CTCAE v4.03.
- measure
- Feasibility of MRg-FU Treatments to the Head and Neck Region
- timeFrame
- 90 days
- description
- The number of patients that meet the eligibility criteria and are able to complete the study treatment protocol.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Able to give informed consent * Weight \<140kg * Biopsy-proven diagnosis of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma from any primary site with demonstrated metastatic nodal disease in the head and neck region * Assessed by the treating surgeon, and radiation oncologist, and following a multidisciplinary discussion, determined to have unresectable and/or inoperable disease in the head and neck region in the presence or absence of distant metastases. * Radiologic evidence of neck lymphadenopathy with at least one target lesion measuring \> 1cm in largest dimension. (Recurrent or initial presentation) * Assessed by the treating radiation/medical oncologists to undergo palliative radiotherapy and/or chemotherapy * Target lesion visible by non-contrast MRI * Target lesion accessible for MRg-FU procedure * Able to communicate sensation during MRg-FU treatment Exclusion Criteria: * Pregnant / Nursing woman * Unable to have contrast-enhanced MRI scan - standard institutional criteria * Head and neck surgery(excluding biopsy) ≤ 6 weeks prior to study enrolment * Chemotherapy ≤ 6 weeks prior to enrolment * Previous radiotherapy to target region ≤ 6 weeks prior to enrolment * Target lesion involves the skin surface causing ulceration, bleeding or discharge * Target lesion in contact with hollow viscera * Target lesion located in skull, spine, or mandible * Fibrotic scar along proposed HIFU beam path * Orthopaedic implant along proposed HIFU beam path or at site of target lesion. * Severe cardiovascular, neurological, renal or hematological chronic disease * ECOG (Eastern Cooperative Oncology Group) Performance Status ≥ 3. * Active infection * Unable to tolerate required stationary position during treatment * Allergy to MRI contrast agent or sedation
References
Publications (0)
Data not yet available