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

NCT01411579 | Completed DMC

• 2 other identifiers: DWIPRECHEMOUTSIRM DWITALY
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastases; Hepatocarcinoma

Keywords

liver; metastases; hepatocarcinoma; MR; DWI; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Apparent Diffusion Coefficient (ADC) value changes of the lesion during chemotherapy.

  Linear regression analysis to assess the association between the ADC-value changes and the CHT outcome.

  For metastasis: 2-4-8 weeks after CHT; for HCC: 30-60-90 days after CHT.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with liver metastases in chemotherapy and with hepatocarcinoma in therapy with Sorafenib

You may qualify if:

• 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.

Sponsors & Collaborators

• Stefano Colagrande: lead
• Società Italiana Radiologia Medica SIRM: collaborator
• Treviso cà Foncello Hospital: collaborator
• University of Trieste: collaborator
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator
• Santa Maria delle Grazie Hospital: collaborator
• Azienda Ospedaliera Niguarda Cà Granda: collaborator
• University of Rome Tor Vergata: collaborator

Study Sites (1)

Stefano Colagrande

Florence, Italy, 50134, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Colagrande, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2013
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

IT (1)