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Optical detection of malignancy during percutaneous interventions.


- candidate number13410
- NTR NumberNTR3651
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-okt-2012
- Secondary IDsNL40578.031.12 CCMO
- Public TitleOptical detection of malignancy during percutaneous interventions.
- Scientific TitleDiscrimination of benign and malignant human tissue during percutaneous interventions using optical spectroscopy techniques.
- ACRONYMPercuSpect
- hypothesisThe hypothesis is that incorporation of this technique into existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of these devices.
- Healt Condition(s) or Problem(s) studiedColon Cancer Liver Metastasis, Pulmonary Coin Lesion
- Inclusion criteria1. Patients with a suspicious lesion in lung or liver who are scheduled for a standard core biopsy procedure;
2. Patient planned for percutaneous RFA of colorectal liver metastasis;
3. Written informed consent;
4. Patients ≥ 18 years old.
- Exclusion criteria1. Patients who have higher risk of bleeding;
2. Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 8-okt-2012
- planned closingdate1-jul-2013
- Target number of participants70
- InterventionsHistological biopsy procedure (standard core biopsy procedure).
- Primary outcomeDifferentiation between normal and malignant tissue. Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations.
- Secondary outcomeN/A
- TimepointsDay: 0
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.D. Berg-Dams, van den
- CONTACT for SCIENTIFIC QUERIES S.D. Berg-Dams, van den
- Sponsor/Initiator Philips NV
- Funding
(Source(s) of Monetary or Material Support)
Philips Health Care
- PublicationsN/A
- Brief summaryInvestigation of application possibilities of optical spectroscopy within the field of oncology. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of these devices. The purpose is to improve and speed up the diagnostics and therapy of the malignacies.
- Main changes (audit trail)
- RECORD4-okt-2012 - 22-okt-2012


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