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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. Identifier: NCT03718650
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : June 5, 2020
Varian Medical Systems
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
At present there is no validated prognostic tool for patients with resectable pancreatic cancer (RPC) to determine how best to tailor individual therapy. This study is to see if tumor features in blood and imaging prior to surgery correspond with tumor heterogeneity in the specimen after surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Resectable Pancreatic Cancer Drug: Pimonidazole Procedure: Surgical Resection Early Phase 1

Detailed Description:
This study is to prospectively determine whether there is a predictive relationship in RPC between pre-operative radiomic imaging features and pathologic tumor heterogeneity, delineated by gene-expression-based RSI and histologic measures of hypoxia measured by Glut-1 and CA-IX as well as the degree of pimonidazole staining.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer: Establishing the Radiomic/Pathologic Foundation of Heterogeneity
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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).
Drug: Pimonidazole
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.
Other Names:
  • HydroxyProbe
  • Pimonidazole HCI

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.
Other Names:
  • Whipple Procedure
  • Pancreatoduodenectomy
  • Surgery

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age and older who have biopsy-proven resectable pancreatic cancer
  • Participants must have a histological diagnosis of pancreatic head ductal adenocarcinoma at least ≥ 1 cm from ampula.
  • Participants must be able to undergo all 3 imaging modalities.
  • Participants' medical statuses must be considered appropriate for surgery and for general anesthesia.
  • Female participants and female partners of male participants undergoing optional PET-CT or CT pancreatic protocol scan cannot be pregnant or nursing, as confirmed by serum pregnancy test if the patient is a woman of child-bearing potential.
  • All female participants of child-bearing potential must agree to use birth control, including oral, injectable, or mechanical contraception, abstinence, or vasectomy for 30 days following pimonidazole administration.
  • Adequate kidney and liver function as assessed by laboratory studies. Laboratory studies must be completed within 28 days prior to pimonidazole administration;
  • Must be capable of providing informed consent and demonstrate a willingness to comply with all the study procedures and visits;
  • Must be able to undergo MRI scans without having a pacemaker or other indwelling metal, which would contraindicate the scan.
  • Have an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Participants who are contraindicated for MRI or gadolinium contrast agents.
  • If the patient has an iodine contrast allergy, they must be able to take standard pre-medications so they can safely undergo a CT scan.
  • Participants with a known active cancer with a prognosis that would contraindicate a curative intent pancreatic resection.
  • Participants with depressed liver function, as assessed with a screening liver function test yielding serum ALT or AST greater than the IULN or total bilirubin greater than 2 mg/dL.
  • Presence of any other co-existing condition, which, in the judgment of the investigator, might increase the risk to the patient.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03718650

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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Contact: Gretchen Macmillan, RN    813-745-8443   
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         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Varian Medical Systems
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Principal Investigator: Sarah Hoffe, MD H. Lee Moffitt Cancer Center and Research Institute
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT03718650    
Other Study ID Numbers: MCC-19599
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases