|- candidate number||14963|
|- NTR Number||NTR4026|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jun-2013|
|- Secondary IDs||NL42902.031.12 MEC|
|- Public Title||In vivo REsponse evaluation of colorectal liver metastases during systemic therapy using optical SPECTroscopy techniques
|- Scientific Title||In vivo REsponse evaluation of colorectal liver metastases during systemic therapy using optical SPECTroscopy techniques
a pilot study|
|- hypothesis||The aim of this pilot study is to investigate whether chemotherapy response can be detected with optical spectroscopy (diffuse reflectance and fluorescence spectroscopy) in patients with unresectable colorectal liver metastases receiving first line systemic therapy.
|- Healt Condition(s) or Problem(s) studied||Inoperable cancer, Colorectal metastised cancer|
|- Inclusion criteria||1. Patients with unresectable colorectal liver metastases;|
2. The liver lesions are safely accessible according to an intervention-radiologist;
3. First line systemic treatment with Capacitabin and Oxaliplatin or FOLFOX, both with or without biologicals;
4. Written informed consent >18y.
|- Exclusion criteria||1. Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy;|
2. Patients with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgery;
3. Patients using any anti-coagulant medication at the time of biopsy: all aspirin derivatives, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted;
4. Patients with indequate hematology and coagulation status as measured by:
* Hb < 6.0 mmol/L;
* Platelet count < 100 x 109/L;
* PT < 1.5 x Upper limit of normal (ULN);
* APTT < 1.5 x ULN;
* PT-INR < 1.5 on the day of biopsy in patients using coumarines;
* Patients known with contraindications for lidocaine (or its derivatives).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||21-jun-2013|
|- planned closingdate||31-dec-2013|
|- Target number of participants||22|
|- Interventions||Histological biopsy procedure (standard core biopsy procedure) - before and after stardard of care chemotherapy.|
|- Primary outcome||The aim of this pilot study is to investigate whether chemotherapy response can be detected with optical spectroscopy (diffuse reflectance and fluorescence spectroscopy) in patients with unresectable colorectal liver metastases receiving first line systemic therapy.
|- Secondary outcome||1. To compare the accuracy of chemotherapy response using optical spectroscopy with standardized RECIST criteria;|
2. To correlate spectroscopic measurements with tissue characteristics from biopsies;
3. During the measurement procedure, possible improvements to the measurement hardware will be recorded which can provide information for possible alterations of hardware design for improved clinical applicability in the future.
|- Timepoints||Day 0 and day of first response monitoring|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Torre Bydlon|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Torre Bydlon|
|- Sponsor/Initiator ||Philips Research Eindhoven|
(Source(s) of Monetary or Material Support)
|- Brief summary||Response monitoring of patients undergoing systemic therapy for colorectal liver metastases in the era of new targeted drugs is troublesome and the development of new monitoring tools is needed. The primary aim of this pilot study is to investigate whether chemotherapy response can be detected with optical spectroscopy in patients with unresectable colorectal liver metastases receiving first line systemic therapy. Optical spectroscopy measurements will be acquired from normal liver tissue and the liver metastasis; a biopsy will also be taken. This will be done prior to the start of systemic therapy and at the first response monitoring moment.
|- Main changes (audit trail)||1-7-2013:|
The Percuspect study is extended to breast cancer patients. 36 additional patients with this condition will be included. METC of NKI approved this modification per April 25, 2013.
Due to this change, the inclusion criteria are extended with the following:
Breast Specific Inclusion criteria
- Breast patients with a BIRADS score 4 or 5
Breast Specific Exclusion criteria
- Patients who have a history of breast cancer and/or who have received prior chemotherapy, endocrine therapy, or radiation therapy
- Patients who have breast implants
- Patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque lesions).
|- RECORD||6-jun-2013 - 1-jul-2013|