Recruiting

Computed Tomography

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02361320

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography (CT)

Questionnaire

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Study ID

NCT02361320

Start date

Mar 9, 2015

Status verified date

Jul, 2026

Completion date

Jun 27, 2028

Anticipated

Primary completion date

Jun 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of distant metastasis
  • Patients whose tumors are defined as resectable
  • Unstable angina or New York Heart Association grade II or greater congestive heart failure
  • Evidence of fever or acute infection (chronic infection such as hepatitis virus is acceptable)
  • Coexisting medical condition that would preclude chemotherapy, radiotherapy, or iodine-based contrast enhanced CT scan
  • Pregnant women with a positive pregnancy test
  • Inability to comply with study and/or follow-up procedures
  • Patients with an active second malignancy with the exception of non-melanoma skin cancer

Study Design

Enrollment

259 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Computed Tomography (CT)

Participants to receive 2 CT scans. One scan performed before the start of chemotherapy, and the other at first restaging visit with oncologist.

Questionnaire

Participant to complete the MD Anderson Symptom Inventory for Gastrointestinal cancer (MDASI-GI) questionnaire at baseline visit, and follow up visit. Questionnaires should take about 10 minutes to complete.

Primary outcome measure

  • Correlation Between Local Control and Changes in Mass Transport by Computed Tomography (CT) [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Eugene Koay

713-563-2300ekoay@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Eugene J. Koay

713-563-2300

Principal Investigator:

Eugene J. Koay

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Pancreatic cancer
  • Pancreatic ductal adenocarcinoma
  • PDAC
  • Computed tomography
  • CT
  • Questionnaire
  • Survey

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-21.