Status:
COMPLETED
Evaluating Bacterial Response in Sarcoma Management Using Fluorescence Imaging
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Mount Sinai Hospital, Canada
Conditions:
Soft Tissue Sarcoma
Wounds
Eligibility:
All Genders
18+ years
Brief Summary
The investigators have recently developed an innovative optical molecular imaging platform (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a hand-held, real-time...
Detailed Description
Optical Tracking System For this study, PRODIGI was combined with a commercial optical tracking system (OTS, Polaris, NDI Medical, Waterloo, Ontario, Canada) to track the movement of the device in sp...
Eligibility Criteria
Inclusion
- Histologically-proven soft tissue sarcoma following review by local reference pathologist.
- Deemed appropriate for preoperative radiotherapy and limb salvage surgery following patient assessment by a radiation oncologist and surgical oncologist and after discussion between both specialists.
- Lesion lies distal to the iliac crest and proximal to the ankle.
- Lesion is primary or locally recurrent. Patient may have undergone excisional biopsy with positive margins at a referring hospital and are eligible following discussion among the surgical oncologists and radiation oncologists that IMRT is an acceptable treatment for that case.
- Patient is aged 18 years or older.
- Patient must be available for treatment and follow-up at Mount Sinai Hospital/Princess Margaret Hospital.
- Protocol treatment is to begin within 4 weeks of entry.
- Patients must be capable of giving informed consent, and informed consent must be obtained according to local Research Ethics Board (REB) requirements.
Exclusion
- Benign histology.
- Histology generally treated with adjuvant chemotherapy, such as rhabdomyosarcoma, primitive neurectodermal tumor (PNET), soft tissue Ewing's sarcoma or soft tissue osteosarcoma.
- Prior or concurrent malignancy, with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
- Limb conservation is not appropriate.
- Prior radiotherapy to the local site or chemotherapy.
- Pathological review of total specimen required before the need for irradiation can be assessed.
- Chemotherapy is required as an adjuvant treatment.
- Presence of regional nodal disease or unequivocal distant metastases.
- Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up.
- Treatment with an investigational drug within 1 month before study enrolment.
- Any contra-indication to routine wound care and/or monitoring.
- Patients with pre-existing skin issues (e.g. melanomas, psoriasis) in areas close to the potential wound(s) that will be studied
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02270086
Start Date
August 1 2011
End Date
May 1 2015
Last Update
September 7 2016
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5T 2M9