Use of DwI-MR to Predict Chemotherapy Response of Liver Metastases and Hepatocarcinoma
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Purpose
One of the most recent and interesting field of diagnostic imaging is diffusion-weighted MR imaging (DW-MRI). Various studies evaluated the application of DW-MRI to diffuse liver disease and focal liver lesions providing controversial results, probably due to the difficult reproducibility of the apparent diffusion coefficient (ADC) measurements. It is conceivable that a wide inter/intra-individual variability actually exists in the apparent diffusion coefficient (ADC)-values, and that each apparent diffusion coefficient (ADC)-value presents an higher reliability in measuring the temporal changes of water diffusion within the same individual (longitudinal-evaluation), than in characterizing tissues between different patients (transverse-evaluation). For these reasons, some previous studies assessed the application of DW-MRI in predicting the chemotherapy (CHT) outcome in liver metastases. The rationale of these studies was the overt biochemical changes shown by the neoplastic cells after CHT and the sensitivity of DW-MRI in the identification of such changes. The same authors noticed that the metastatic lesions with the lowest ADC-values present also the best outcome after CHT. Moreover, these studies suggest that it could be possible to assess if each single patient will respond (R) or not (NR) to the CHT through liver DW-MRI performed from 3 days to 3 weeks after the beginning of CHT.
| Condition |
|---|
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Liver Metastases Hepatocarcinoma |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Assessment of Diffusion-weighted Magnetic Resonance (MR) Imaging to Predict Chemotherapy Outcome in Liver Metastases and Hepatocellular Carcinoma (HCC) |
- Apparent Diffusion Coefficient (ADC) value changes of the lesion during chemotherapy. [ Time Frame: For metastasis: 2-4-8 weeks after CHT; for HCC: 30-60-90 days after CHT. ] [ Designated as safety issue: No ]Linear regression analysis to assess the association between the ADC-value changes and the CHT outcome.
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Clinical Benefit
The patients responding to the chemotherapy, i.e. who show at least a non progressive disease
|
|
Non responder
The patients non responding to the chemotherapy, i.e. who show a progressive disease
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with liver metastases in chemotherapy and with hepatocarcinoma in therapy with Sorafenib
Inclusion criteria:
- of age, compliant, patients enrolled for CHT, without major contraindications to the MR examination;
- non-confluent liver metastases, from every primary carcinoma histotype biopsy/surgical-proven, without intralesional necrosis/calcification involving >30% of their volume;
- at least one marker lesion allowing reproducible ADC measurements, i.e. placed at the level of the lower right liver segments;
- multiple confluent hepatocellular carcinomas, histotype biopsy/surgical-proven in prevision of treatment with Sorafenib;
- detection/enrolment by contrast-enhanced CT before CHT that allow to define the lesion size or the gross parenchymal involvement (if HCC)
Each patient will sign an informed consent, after the procedure will be completely explained.
For the metastasis: Three diameter of each marker lesion will be measured, and the mean/minimal/maximal ADC±standard deviation will be quantified by region-of-interests (ROIs) placed within the lesion avoiding lesion margins and the necrotic/intratumoral calcification areas.
For the hepatocarcinoma: Three diameter of gross parenchymal involvement will be measured, and the mean/minimal/maximal ADC±standard deviation will be quantified by large region-of-interests (ROIs) placed within the the lobe containing the involvement.
All measurements will be repeated for three times even at the level of the adjacent liver parenchyma (within 3 cm from the lesion margins, keeping a ROI diameter >2 cm). Consequently, the absolute values (s/mm2) of ADC, and the ADC percentages vs. the adjacent liver parenchyma measured at the different times will be compared.
Contacts and Locations| Contact: Stefano Colagrande, Prof. | stefano.colagrande@unifi.it | |
| Contact: Francesco Mungai, MD | f.mungai@gmail.com |
| Italy | |
| Stefano Colagrande | Recruiting |
| Florence, Italy, 50134 | |
| Contact: Stefano Colagrande, Prof. stefano.colagrande@unifi.it | |
| Contact: Francesco Mungai, MD f.mungai@gmail.com | |
| Principal Investigator: | Stefano Colagrande, MD | University of Florence |
More Information
No publications provided
| Responsible Party: | Stefano Colagrande, Associate Professor of Radiology, University of Florence |
| ClinicalTrials.gov Identifier: | NCT01411579 History of Changes |
| Other Study ID Numbers: | DWIPRECHEMOUT, SIRM DWITALY |
| Study First Received: | August 5, 2011 |
| Last Updated: | August 16, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Florence:
|
liver metastases hepatocarcinoma |
MR DWI chemotherapy |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Liver Neoplasms Carcinoma, Hepatocellular Neoplastic Processes Neoplasms Pathologic Processes Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 22, 2013