Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

NCT ID: NCT03718650

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-04-01

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.

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.

Conditions

Pancreatic Cancer; Resectable Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Pimonidazole

Intervention Type: DRUG

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.

Surgical Resection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

HydroxyProbe; Pimonidazole HCI; Whipple Procedure; Pancreatoduodenectomy; Surgery

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Hoffe, MD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-19599

Identifier Type: -

Identifier Source: org_study_id