No registrations found.
ID
Source
Brief title
Health condition
unresectable colorectal liver metastases
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
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.
Study objective
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.
Study design
Day 0 and day of first response monitoring
Intervention
Histological biopsy procedure (standard core biopsy procedure) - before and after stardard of care chemotherapy.
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
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
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.
Breast Specific Inclusion criteria
- Breast patients with a BIRADS score 4 or 5
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).
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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3838 |
NTR-old | NTR4026 |
CCMO | NL42902.031.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON38470 |