We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Use of DwI-MR to Predict Chemotherapy Response of Liver Metastases and Hepatocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01411579
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : December 10, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Liver Metastases Hepatocarcinoma

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 57 participants
Time Perspective: Prospective
Official Title: Assessment of Diffusion-weighted Magnetic Resonance (MR) Imaging to Predict Chemotherapy Outcome in Liver Metastases and Hepatocellular Carcinoma (HCC)
Study Start Date : February 2011
Primary Completion Date : February 2012
Study Completion Date : February 2013
Groups and 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

Outcome Measures

Primary Outcome Measures :
  1. 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. ]
    Linear regression analysis to assess the association between the ADC-value changes and the CHT outcome.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411579

Stefano Colagrande
Florence, Italy, 50134
Sponsors and Collaborators
Stefano Colagrande
Società Italiana Radiologia Medica SIRM
Treviso cà Foncello Hospital
University of Trieste
Azienda Ospedaliera Spedali Civili di Brescia
Pozzuoli Santa Maria delle Grazie Hospital
Azienda Ospedaliera Niguarda Cà Granda
University of Rome Tor Vergata
Principal Investigator: Stefano Colagrande, MD University of Florence
More Information

Responsible Party: Stefano Colagrande, Associate Professor of Radiology, University of Florence
ClinicalTrials.gov Identifier: NCT01411579     History of Changes
Other Study ID Numbers: DWIPRECHEMOUT
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Stefano Colagrande, University of Florence:

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type