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…
ID
Bron
Verkorte titel
Aandoening
unresectable colorectal liver metastases
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Day 0 and day of first response monitoring
Onderzoeksproduct en/of interventie
Histological biopsy procedure (standard core biopsy procedure) - before and after stardard of care chemotherapy.
Algemeen / deelnemers
Philips Research - Minimally Invasive Healthcare Department
High Tech Campus 34 (Room 2.035)
Torre Bydlon
Eindhoven 5656 AE
The Netherlands
+31 40 2748875
Torre.Bydlon@philips.com
Wetenschappers
Philips Research - Minimally Invasive Healthcare Department
High Tech Campus 34 (Room 2.035)
Torre Bydlon
Eindhoven 5656 AE
The Netherlands
+31 40 2748875
Torre.Bydlon@philips.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Breast Specific Inclusion criteria
- Breast patients with a BIRADS score 4 or 5
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
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).
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL3838 |
NTR-old | NTR4026 |
CCMO | NL42902.031.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON38470 |