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Magnetic nanoparticle thermoablation -– retention and maintenance in prosta... | Not Recruiting
Magnetic nanoparticle thermoablatio... | Not Recruiting
Magnetic nanoparticle thermoablation -– retention and maintenance in prostate
MAGNABLATE I

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Medical Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Prostate Cancer
  • Disease: Prostate
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN96083641
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-nanoparticles-heat-destroy-prostate-cancer-magnablate-i-trial
Research Details
  • This Phase 0 dose escalation safety trial aims to evaluate the retention of magnetic nanoparticles in the prostate.

    The primary study objectives are:-
    1. To conduct a dose escalation safety trial of magnetic nanoparticles injected into the prostates of men prior to cystoprostatectomy.
    2. To conduct a dose escalation safety trial of magnetic nanoparticles injected into the prostates of men prior to prostatectomy.
    3. To evaluate ex-vivo prostates with a special marker to determine the retention and distribution of the magnetic nanoparticles in relation to the intended target area at time of injection.

    The secondary study objectives are:-
    To evaluate the anatomical distribution of magnetic nanoparticles compared with injection site in prostate assessed by both Perls’ staining and postoperative imaging (MRI and CT) of the ex vivo tissue.
Phase
Not Applicable
Study Design
Non-randomised interventional treatment trial
Study Type
Interventional
Intervention

The trialists are aiming for a minimum of 60% of injected nanoparticles to be retained within the prostate over an average of first 6 patients. They aim to recruit a representative group of men who have overt cancer lesions as well as overt benign areas for injection.
They are aiming for the following:
Minimum number of benign prostate lobes 12
Minimum number of malignant lobes 6
Men undergoing Radical Cystoprostatectomy and Radical Prostatectomy will be recruited until the above numbers are fullfilled.

Injection of nano-particles, Pre-operative preparation: This procedure will be carried out just prior to the surgery (cystoprostatectomy or prostatectomy). The patient will be admitted on the morning of the procedure. The patient will be asked to sign the hospital procedure specific consent form.
Procedure set-up: Intravenous antibiotics (Gentamicin 120mg and Cefuroxime 1.5gm) are given just prior to injection unless contra-indicated.
The injection will be administered under general anaesthetic.

Surgery, Removal of prostate during radical cystoprostatectomy or radical prostatectomy surgery
Post-procedure care: The patient is discharged home once he has recovered from his major surgery as per standard of care. A contact number is given to the patient to call if any problems are encountered.

Intervention Type
Other
Primary Outcome Measures
    Rate of serious and other adverse events; Timepoint(s): For the duration the patient is in the study
Secondary Outcome Measures
    1. Anatomical distribution of magnetic nanoparticles compared with injection site in prostate; Timepoint(s): On removal of the prostate
    2. Percentage microsphere retention using Perl staining on whole-mount histology; Timepoint(s): At removal of the prostate
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 18; UK Sample Size: 18
Participant Inclusion Criteria
    1. Men undergoing:
    1.1. Radical cystoprostatectomy for bladder cancer, or
    1.2. Radical prostatectomy for prostate cancer
    2. Men able to give informed consent
Participant Exclusion Criteria
    1. Have taken any form of hormones (except 5alpha
    reductase inhibitors) within the last 6 months
    2. Unable to have MRI scan or CT scan, or in whom artefact would reduce scan quality
    3. Unable to have general or regional anaesthesia
    4. Men on immunosuppression or predefined immunosuppressed state
    5. Men with a coagulopathy predisposing to bleeding to clot formation
    6. Men with an inherited or acquired condition limiting metabolism of iron
    7. Unable to give informed consent
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
W1W 7EJ
Trial Contact(s)
Primary Trial Contact
Ms Chris Brew-Graves
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
MAGnetic NAnoparticle thermoaBLATion -– retention and maintenance in prostatE: a Phase 0 study in men (MAGNABLATE I trial)
EudraCT Number
Sorry, this information is not available
Funder(s)
  • NIHR (UK) - Central Commissioning Facility
Other Study ID Numbers
15516
Sponsor(s)
University College London (UK)
Key Dates

Recruitment Start Date

04 Dec 2013

Recruitment End Date

03 Dec 2014

Trial Start Date

04 Dec 2013

Trial End Date

03 Dec 2014

Date added to source

17 Dec 2013

Date updated in source

13 Mar 2017