Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03718650|
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Resectable Pancreatic Cancer||Drug: Pimonidazole Procedure: Surgical Resection||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer: Establishing the Radiomic/Pathologic Foundation of Heterogeneity|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
Experimental: Scans, Surgical Resection and Assessment
Pre-surgery scans, surgical resection and post-surgery pathological assessment. All patients will receive standard of care imaging and blood tests. If suitable, non-standard of care abdominal MRI imaging will be done. 16-24 hours prior to surgery, patients will be administered a single dose of 0.5 g/m^2 pimonidazole (HydroxyProbe).
Patients will take a single dose of 0.5 g/m^2 (approximately 13 mg/kg) of oral pimonidazole HCI 16 to 24 hours prior to surgery.
Procedure: Surgical Resection
Patients will undergo Pancreaticoduodenectomy or Whipple procedure, which involves the resection of the pancreatic head, duodenum, gallbladder, and a portion of the stomach, 16 to 24 hours after consuming oral pimonidazole.
- Radiosensitivity Index and Degree of Pimonidazole Staining [ Time Frame: Up to 14 weeks ]Relationship between PET/CT, MRI or pancreas protocol CT features and the pathological correlations of radiation sensitivity and hypoxia, as measured by the radiosensitivity index (RSI) and degree of pimonidazole staining in resectable pancreatic cancer.
- Correlative Biomarkers [ Time Frame: Up to 14 weeks ]Investigators will quantitiatively compare correlative biomarkers with the degree of pimonidazole staining and RSI. These biomarkers will include radiomic features from the preoperative imaging tests, serum CA 19-9, and histological markers for biological hypoxia, GLUT-1, and CA-IX. Data from all of these biomarkers will be available as continuous variables. The association between RSI (or % pimonidazole-positive pixels) and biomarkers will be assessed using the Spearman correlation analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718650
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Gretchen Macmillan, RN 813-745-8443 email@example.com|
|Principal Investigator: Sarah Hoffe, MD|
|Principal Investigator: Robert Gillies, PhD|
|Sub-Investigator: Jimmy Caudell, MD, PhD|
|Sub-Investigator: Barbara Centeno, MD|
|Sub-Investigator: Sean Dineen, MD|
|Sub-Investigator: William DominguezViqueira, PhD|
|Sub-Investigator: Heiko Enderling, PhD|
|Sub-Investigator: Jason Fleming, MD|
|Sub-Investigator: Jessica Frakes, MD|
|Sub-Investigator: Kenneth Gage, MD|
|Sub-Investigator: Louis Harrison, MD|
|Sub-Investigator: Pamela Hodul, MD|
|Sub-Investigator: Jason Klapman, MD|
|Sub-Investigator: Kujtim Latifi, PhD|
|Sub-Investigator: Mokenge Malafa, MD|
|Sub-Investigator: Gary Martinez, PhD|
|Sub-Investigator: Eduardo Moros, PhD|
|Sub-Investigator: Jose Pimiento, MD|
|Principal Investigator:||Sarah Hoffe, MD||H. Lee Moffitt Cancer Center and Research Institute|