Pancreatic CancerNCT02361320
Computed Tomography in Diagnosing Patients With Pancreatic or Hepatobiliary Cancer
A study testing Computed Tomography (CT) and Questionnaire in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Computed Tomography (CT) and Questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2015to 27 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Eugene J. Koay, 713-563-2300
Eugene J. Koay
About this study
Official title: Imaging Biomarkers in Pancreatic and Hepatobiliary Cancers
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Computed Tomography (CT), Questionnaire
- Keywords
- Pancreatic cancer, Pancreatic ductal adenocarcinoma, PDAC, Computed tomography, CT, Questionnaire, Survey
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography (CT)Procedure or surgery
Also called CT
Participants to receive 2 CT scans. One scan performed before the start of chemotherapy, and the other at first restaging visit with oncologist.
QuestionnaireBehavioural
Also called Survey
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography (CT); Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study start9 Mar 2015
- Primary completion27 Jun 2028 (estimated)
- Study completion27 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 259 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eugene Koay, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361320
- Sponsor's protocol ID
- PA14-0319
- Other IDs
- NCI-2018-02642, PA14-0319
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2015
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Biomarkers in Pancreatic and Hepatobiliary Cancers
- ClinicalTrials.gov ID
- NCT02361320
- Acronym / sponsor ID
- PA14-0319
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Pancreatic ductal adenocarcinoma, PDAC, Computed tomography, CT, Questionnaire, Survey
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 259 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 27 Jun 2028 (estimated)
- Study completion
- 27 Jun 2028 (estimated)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computed Tomography Scans (CT) | Experimental | Procedure: Computed Tomography (CT), Behavioral: QuestionnaireParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- PANCREATIC CANCER: Histologically confirmed adenocarcinoma of the pancreas
- PANCREATIC CANCER: Non-distant metastatic pancreatic cancer that is either
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography (CT)Also: CTParticipants to receive 2 CT scans. One scan performed before the start of chemotherapy, and the other at first restaging visit with oncologist. | Procedure or surgery | Computed Tomography Scans (CT) |
| QuestionnaireAlso: SurveyParticipant 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. | Behavioural | Computed Tomography Scans (CT) |
Primary outcome
Correlation Between Local Control and Changes in Mass Transport by Computed Tomography (CT)
Time frame: 4 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eugene Koay principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography (CT) and Questionnaire in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eugene Koay (713-563-2300, ekoay@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Local Control and Changes in Mass Transport by Computed Tomography (CT) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.