A Phase 1/2 interventional study of Light activated WST11 in Renal Cancer, sponsored by University of Oxford. Terminated at 1 site in United Kingdom. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by University of Oxford · Phase 1/2, Interventional, and Treatment
Vascular Targeted Photodynamic therapy (VTP) with the Vascular Occluding Agent (VOA) WST11, may offer an alternative, providing tumour destruction via a minimally invasive approach. In this investigation, the investigators plan to use the WST11 VTP procedure to treat a predetermined small renal tumour targets. Patients will be given a general anaesthetic, to ensure immobility, and prevent discomfort during treatment sessions. Treated patients will then undergo surgical resection of their tumours, and the accuracy and reliability of tissue death with VTP will be assessed histologically. The aim of this proof of concept study is to demonstrate whether this modality has potential for a clinical role in the treatment of oncological kidney disease, either as an alternative to surgery, or where surgery is not feasible.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 5 is below the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
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Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
Drug: Light activated WST11
WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 mg/kg, or 4mg/kg using 753 nm laser light at a fixed power (150 mW/cm) and energy (200 J/cm) delivered through percutaneous optical fibres. The fibres are introduced into transparent needles that are positioned in the areas of interest under CT image guidance. After a minimum of 3 patients at each drug dosage (2 \& 4 mg/kg) has been treated with a light energy of 200 J/cm, the general and local safety will be assessed. The safety results of the first 3 patients treated in each drug dose/number of fibres combination will be reviewed by the investigators prior to escalation to a higher drug dose/number of fibres combination.
Also known as: Tookad Soluble
Volume of tumour necrosis on final histology expressed as a percentage of pre-treatment tumour volume
Time frame: 2-4 weeks post VTP therapy
Radiological evidence of tissue destruction at day 12 (technical success) based on the volume of tumour ablation on day 12 MRI imaging expressed as a percentage of pre-treatment tumour volume
Time frame: 12 days post VTP therapy
Adverse events according to Common Toxicity Criteria (CTCAE)
Time frame: Up to 12 months post VTP
This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of Oxford