Dynamic Contrast Enhanced HCC SABR Liver Study

NCT02847767 | Unknown

• 1 other identifier: H15-02341
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The high dose per fraction (\>10Gy/fraction) used in Stereotactic Ablative Body Radiotherapy (SABR) has been shown to be more effective at local tumor control than treatments employing more conventional dose fractions. The mechanisms for this are currently under debate. One possible mechanism for this increased effectiveness is that high dose/fraction causes significant vascular damage to the tumor. This study hopes to measure vascular integrity pre and post SABR treatment using kinetic models obtained from dynamic contrast enhanced CT.

Conditions

Carcinoma, Hepatocellular

Keywords

Liver Perfusion; Hepatocellular Carcinoma; Dynamic Contrast-Enhanced Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Changes in tumour vasculature as assessed by changes PL derived model parameters

  To quantify changes in tumor vascular support for patients receiving SABR.

  1 week after cancer treatment

Secondary Outcomes (1)

• Association (correlation) between aggregate QOL scores and PK derived model parameters

  1 week after cancer treatment

Study Arms (1)

Perfusion Imaging

EXPERIMENTAL

IV contrast perfusion CT will be performed at baseline and at 1 week after completing treatment. Perfusion imaging is similar to a diagnostic CT except a smaller region is serially imaged post contrast injection with multiple data acquisitions and high temporal resolution.

Procedure: Perfusion Imaging

Interventions

Perfusion Imaging PROCEDURE

IV contrast perfusion CT will be performed at baseline and at 1 week after completing treatment. Perfusion imaging is similar to a diagnostic CT except a smaller region is serially imaged post contrast injection with multiple data acquisitions and high temporal resolution

Perfusion Imaging

Eligibility Criteria

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

You may qualify if:

• All the following criteria must be met:
• Age \> 18 years old
• Multi-phase CT scan and/or MRI of the liver within 8 weeks of radiation planning demonstrating:
• Liver tumours \< 5 cm
• No more than 2 discrete liver tumours
• Normal liver \> 700 cc
• Patients must have HCC diagnosed by either: i) pathological confirmation, or ii) intrahepatic vascular enhancement of the lesion demonstrated by at least two imaging modalities, or iii) intrahepatic vascular enhancement of the lesion demonstrated by one imaging modality if AFP \> 200 in the setting of liver cirrhosis or chronic hepatitis B without cirrhosis (EASL consensus guidelines \[2\])
• Liver HCC must be deemed unresectable as determined by an experienced hepatobiliary surgeon, or the patient must be medically inoperable or refuse surgery,
• Patients must be discussed in a multidisciplinary setting, with representatives from Medical Oncology, Radiation Oncology, Surgery, Interventional Radiology, and Hepatology. Patients must be considered ineligible for standard local treatments, including surgery, liver transplantation, radiofrequency ablation, and targeted biologics. Some subjects could be potential candidates for sorafenib but normally this treatment is not considered before all local treatment options have been considered, as the response rate to sorafenib is low (2% in the SHARP study). Patients might be candidates for sorafenib after progression on the study treatment or if they do not want to participate and in both cases they will be referred to a medical oncologist. Patients may have received prior TACE and had an incomplete response. Ineffective or incomplete TACE is defined as incomplete filling by lipiodol-doxorubicin mixture used by either angiography or CT ≥1 month after TACE or by increasing alpha-fetoprotein level. Patients must have recovered from the effects of previous therapies before SBRT with a minimum 4-week period between TACE and SBRT.
• Eastern Clinical Oncology Group performance status 0, 1, or 2 (Appendix III), or a Karnofsky performance status of ≥ 60 (Appendix IV)
• Adequate organ function as assessed by the following blood work:
• Hemoglobin ≥ 90 g/L
• Absolute neutrophil count ≥ 1.0 bil/L
• Platelets ≥ 50 bil/L
• AST and ALT not to exceed 3x upper limit of normal

You may not qualify if:

• Patient signs a study-specific informed consent form. If the patient's mental status precludes this, written informed consent may be given by the patient's legal representative. A translator will be provided if the patient has a language barrier.
• Treatment plans meet acceptable dose constraints and Liver Veff is ≤ 0.55
• Patients with active hepatitis, encephalopathy, or ascites related to liver failure
• Female patients who are pregnant (verify with blood test if patient is pre-menopausal). Pre-menopausal patients may also not become pregnant during participation in this study.
• Prior external beam radiation to the upper abdomen
• Patients with distant metastases or extrahepatic nodal progression (patients with portal venous thrombosis and liver hilum nodal involvement remain eligible)
• Patients who have \< 700 cc of normal liver.
• Child-Turcotte-Pugh scores \> 7
• BCLC Stage A, C (N1 and/or M1), D
• Prior gastric, duodenal, or variceal bleed within the past 2 months

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• University of British Columbia: collaborator

Study Sites (2)

BC Cancer Agency Fraser Valley Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BC Cancer Agency Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Francois Benard, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Thomas

CONTACT

604-877-6000; sthomas-02@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, Functional Imaging

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 28, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)