Computed Tomography in Diagnosing Patients with Pancreatic, Hepatobiliary, or Gynecological Cancer
This trial studies how well computed tomography works in diagnosing patients with pancreatic, hepatobiliary, or gynecological cancer. Computed tomography may help researchers predict how patients with pancreatic, hepatobiliary, or gynecological cancer may respond to chemotherapy.
Inclusion Criteria
- PANCREATIC CANCER: Histologically confirmed adenocarcinoma of the pancreas
- PANCREATIC CANCER: Age 18 or older
- PANCREATIC CANCER: Metastatic or 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: Age 18 or older
- 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
- CERVICAL CANCER: Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy
- CERVICAL CANCER: Age 18 or older
Exclusion Criteria
- 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 younger than 18 years of age
- Patients with an active second malignancy with the exception of non-melanoma skin cancer
- Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition. This exclusion applies only to patients who will participate in MRI scans. If patients are only undergoing CT scans, this exclusion does not apply
- Patients who are cognitively impaired
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02361320.
Locations matching your search criteria
United States
Texas
Conroe
Houston
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.
III. To prospectively validate our pilot data that indicate that treatment related changes, including changes in mass transport properties, apply to pre- and post-therapy magnetic resonance (MR) imaging findings in gynecologic cancers.
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. Patients with cervical cancer undergo MRI scans once weekly (QW) during weeks 2 and 3 of radiation therapy. Patients may optionally undergo collection of blood samples on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorEugene Jon Koay
- Primary IDPA14-0319
- Secondary IDsNCI-2018-02642
- ClinicalTrials.gov IDNCT02361320