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Imaging Biomarkers in Pancreatic and Hepatobiliary Cancers

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This trial studies how well computed tomography works in diagnosing patients with pancreatic or hepatobiliary cancer. Computed tomography may help researchers predict how patients with pancreatic or hepatobiliary cancer may respond to chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• PANCREATIC CANCER: Histologically confirmed adenocarcinoma of the pancreas

• PANCREATIC CANCER: Non-distant metastatic pancreatic cancer that is either

‣ Unresectable locally advanced disease, defined as primary tumor that involves \> 180 degrees of the superior mesenteric artery, celiac axis or any of its branches on CT or MRI, primary tumor that occludes the superior mesenteric vein or portal vein, aorta or inferior vena cava invasion, or superior mesenteric vein invasion below the transverse mesocolon

⁃ Borderline resectable disease, defined as primary tumor that involves =\< 180 degrees of the superior mesenteric artery, celiac axis or any of its branches on CT or MRI, primary tumor that involves the superior mesenteric vein causing vein deformity or segmental venous occlusion with a patent vessel above and below suitable for reconstruction, or primary tumor that abuts or encases (\>= 50% of the vessel circumference) a short segment of the common hepatic artery (typically at the gastroduodenal artery origin)

• PANCREATIC CANCER: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

• PANCREATIC CANCER: Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding

• PANCREATIC CANCER: Patient who has been recommended chemotherapy treatment for pancreatic cancer

• PANCREATIC CANCER: Signed study-specific consent form

• HEPATOBILIARY CANCER: Diagnosis of

‣ Hepatocellular carcinoma: This may be diagnosed in the following ways:

• Pathologically (histologically or cytologically) proven diagnosis of hepatocellular carcinoma (HCC)

∙ At least one solid liver lesion with arterial enhancement and washout on a delayed phase of a multi-phasic CT or MRI in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis

⁃ Intrahepatic cholangiocarcinoma: Pathologically (histologically or cytologically) proven diagnosis of intrahepatic cholangiocarcinoma

• HEPATOBILIARY CANCER: Patients may have single or multinodular tumors

• HEPATOBILIARY CANCER: ECOG PS 0-1

• HEPATOBILIARY CANCER: Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception

• HEPATOBILIARY CANCER: Prior history of surgical resection, chemotherapy, transarterial chemoembolization (TACE), and/or radiofrequency ablation are allowed

• HEPATOBILIARY CANCER: Patients may be enrolled if:

‣ The patient is dispositioned to receive definitive radiotherapy

⁃ The patient has received definitive radiotherapy within the past two years and has liver protocol CT or MRI scans before radiotherapy and at first restaging after radiotherapy

• HEPATOBILIARY CANCER: Signed study-specific consent form

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Eugene Koay
ekoay@mdanderson.org
713-563-2300
Time Frame
Start Date: 2015-03-09
Estimated Completion Date: 2026-06-27
Participants
Target number of participants: 259
Treatments
Experimental: Computed Tomography Scans (CT)
Participants to receive 2 computed tomography (CT) scans that are part of their regular cancer care. One (1) scan performed before the start of chemotherapy, and the other at first restaging visit with oncologist. Participant to complete the MD Anderson Symptom Inventory for Gastrointestinal cancer (MDASI-GI) questionnaire at baseline visit, and follow up visit.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov