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Computed Tomography in Diagnosing Patients With Pancreatic or Hepatobiliary Cancer

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography (CT)
Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Pancreatic ductal adenocarcinoma, PDAC, Computed tomography, CT, Questionnaire, Survey

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computed Tomography Scans (CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2015
Last Updated
October 6, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02361320
Brief Title
Computed Tomography in Diagnosing Patients With Pancreatic or Hepatobiliary Cancer
Official Title
Imaging Biomarkers in Pancreatic and Hepatobiliary Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2015 (Actual)
Primary Completion Date
June 27, 2026 (Anticipated)
Study Completion Date
June 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. To prospectively validate our pilot data that indicate that pre-therapy computed tomography-based (CT) mass transport properties correlate with overall survival. II. To prospectively validate our pilot data that indicate that local control of pancreatic and hepatobiliary tumors correlate with changes in computed tomography-based mass transport properties of the tumors after cytotoxic therapies. OUTLINE: Patients undergo CT scan at baseline and after 4 to 6 cycles of fluorouracil/irinotecan/leucovorin calcium/oxaliplatin, or after 4 infusions of gemcitabine/nab-paclitaxel (or other gemcitabine-based regimens), or 6 to 12 weeks after radiotherapy for hepatobiliary cancers. Patients may undergo optional magnetic resonance imaging (MRI) scans prior to therapy, after two weeks of therapy, and at the time of the first restaging CT scan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Pancreatic ductal adenocarcinoma, PDAC, Computed tomography, CT, Questionnaire, Survey

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
259 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computed Tomography Scans (CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography (CT)
Other Intervention Name(s)
CT
Intervention Description
Participants to receive 2 CT scans. One scan performed before the start of chemotherapy, and the other at first restaging visit with oncologist.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Survey
Intervention Description
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 Information:
Title
Correlation Between Local Control and Changes in Mass Transport by Computed Tomography (CT)
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Koay
Phone
713-563-2300
Email
ekoay@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Koay
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene J. Koay
Phone
713-563-2300
First Name & Middle Initial & Last Name & Degree
Eugene J. Koay

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

Computed Tomography in Diagnosing Patients With Pancreatic or Hepatobiliary Cancer

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