NCT02361320

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
2mo left

Started Mar 2015

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Mar 2015Jun 2026

First Submitted

Initial submission to the registry

February 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

March 9, 2015

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

11.3 years

First QC Date

February 4, 2015

Last Update Submit

January 13, 2026

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerPancreatic ductal adenocarcinomaPDACComputed tomographyCTQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Correlation Between Local Control and Changes in Mass Transport by Computed Tomography (CT)

    Local tumor progression defined by clinical signs or symptoms of local pancreatic tumor growth (e.g., worsening back/abdominal pain, obstruction, jaundice, etc.) that are documented by the attending clinician and research data coordinator and/or diagnostic imaging evidence of tumor growth. Kaplan-Meier method used to estimate probabilities of LPFS for patients with a normalized AUC ratio \<1 and patients with a normalized AUC ratio \>/=1, respectively. Log rank test applied to compare the LPFS between these two patient groups. Multivariate Cox proportional hazards models fitted to compare the LPFS between the two comparison groups, adjusting for the effects of patients' characteristics and clinical factors.

    4 months

Study Arms (1)

Computed Tomography Scans (CT)

EXPERIMENTAL

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.

Procedure: Computed Tomography (CT)Behavioral: Questionnaire

Interventions

Computed Tomography (CT)PROCEDURE

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

Also known as: CT
Computed Tomography Scans (CT)
QuestionnaireBEHAVIORAL

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.

Also known as: Survey
Computed Tomography Scans (CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eugene Koay

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugene Koay

CONTACT

713-563-2300ekoay@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 11, 2015

Study Start

March 9, 2015

Primary Completion (Estimated)

June 27, 2026

Study Completion (Estimated)

June 27, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

US(1)