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TerminatedNCT01573156KCM201Updated Jan 10, 2018

Vascular Targeted Photodynamic Therapy T1a Renal Tumours

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

Why this study was terminated
Concerns about post VTP MRI results being conclusive
Phase
Phase 1/2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
60 Years to 90 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Renal Cancer

Keywords

  • renal cancer
  • photodynamic therapy
  • wst 11
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In context

Kidney Neoplasms

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 →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or post-menopausal female, aged 60 years or above.
  • Lesions suspicious for renal cell carcinoma on triple phase CT that are \< 4cm in maximum diameter and suitable for surgical resection
  • Participant must be in sufficiently good health to be suitable for general anaesthesia for both VTP treatment and subsequent surgical resection of tumour
  • Subjects must have ≥ 1 evaluable tumours which can be visualized on diagnostic ultrasound. If more than one tumour exists, an index tumour will be nominated and treated (uncommon)
  • Previous chemotherapy and / or biological therapy for cancer are permitted, but the subject should have recovered fully from the effects of these and any prior surgery (minimum of 28 days).
  • Patients should not have received radiotherapy to the target area within the preceding 12 months.
  • Subject has clinically acceptable haematological, electrolyte and hepatic function as demonstrated by serum laboratory values within 14 days prior of VTP treatment:
  • Absolute neutrophil count (ANC) ≥ 1500mm-3
  • Platelet count ≥ 100,000mm-3
  • Haemoglobin ≥ 10gdl-1
  • Prothrombin time (PT) ≤ 1.5 * Upper Limit of Normal (ULN)
  • Activated partial thromboplastin time (APPT) ≤ 1.5 * ULN
  • Total bilirubin \< 2.5 * ULN
  • Aspartate aminotransferase (AST) \< 3 * ULN
  • Alkaline phosphatase (ALP) \< 2 * ULN; unless arising from bone
  • Participants has a clinically acceptable ECG
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion criteria

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

  • Non menopausal women
  • Significant hepatic impairment.
  • Significant renal impairment as to mean surgical resection is unsuitable
  • Clinical or radiological evidence of metastatic disease
  • Subjects with tumours lying adjacent to vital structures such that VTP treatment would risk damage to these structures
  • Subjects currently taking immunosuppressive medication
  • Patients whose medical conditions need the following medication which have potential photosensitizing effects (tetracyclines, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin and amiodarone (see appendix G)) if these treatments cannot be stopped or replaced by other treatments without photosensitizing properties
  • Patients who have an absolute need for anticoagulant drugs or antiplatelet drugs (e.g., warfarin, aspirin), which cannot be withdrawn during the 10 days prior to the VTP procedure.
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Participants involved in the treatment phase of a clinical trial (observational or follow-up studies will be allowed)
  • An American Society of Anaesthesiologists (ASA) score of ≥ 3
  • A World Health Organization (WHO) performance status of ≥2
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    VTP treatment to small renal mass

    Drug: Light activated WST11

Interventions

  • DrugLight 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

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What researchers measure

Primary outcomes

  1. Volume of tumour necrosis on final histology expressed as a percentage of pre-treatment tumour volume

    Time frame: 2-4 weeks post VTP therapy

Secondary outcomes

  1. 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

  2. Adverse events according to Common Toxicity Criteria (CTCAE)

    Time frame: Up to 12 months post VTP

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Study locations

1 site
  • Churchill Hospital
    Oxford, OX44 9LS, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01573156
Lead sponsor
University of Oxford
Collaborators
Steba Biotech S.A.
Responsible party
Sponsor
First posted
Apr 6, 2012
Start date
May 2013
Primary completion
May 2014
Completion
Jun 2015
Last update
Jan 10, 2018

Study contacts

Mark Sullivan, MD FRCS Urol
principal investigator · Churchill Hospital, Oxford, UK

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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