Minimally-invasive treatment for limb cancer
Minimally-Invasive Isolated Limb Perfusion
Vastra Gotaland Region · NCT03376126
This study is testing a new, less invasive treatment for patients with advanced melanoma or sarcoma in their limbs to see if it works safely and effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region (other gov) |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT03376126 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of a minimally-invasive isolated limb perfusion (MI-ILP) technique for patients with in-transit metastases of melanoma and locally advanced extremity sarcomas. The study will utilize a percutaneous vascular access method guided by ultrasound, connecting to an extracorporeal oxygenation system to conduct perfusion similarly to traditional open ILP. Outcomes, technical details, and complications will be recorded prospectively to assess the effectiveness and safety of this new approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years scheduled for isolated hyperthermic perfusion treatment.
Not a fit: Patients with re-perfusion, lymph node metastases, or severe atherosclerosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a safer and more effective treatment option for patients with specific limb cancers.
How similar studies have performed: While isolated limb perfusion is a well-established method, this minimally-invasive approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient scheduled for treatment with isolated hyperthermic perfusion 2. Age over 18 years. 3. Signed informed consent Exclusion Criteria: 1. Re-perfusion 2. Lymph node metastases 3. Severe atherosclerosis
Where this trial is running
Gothenburg
- Sahlgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
Study contacts
- Study coordinator: Roger Olofsson Bagge, MD, PhD
- Email: roger.olofsson.bagge@gu.se
- Phone: +46 31 3420000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Isolated Limb Perfusion, isolated limb perfusion