Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

NCT03718650 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: MCC-19599
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Radiosensitivity Index and Degree of Pimonidazole Staining

  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.

  Up to 14 weeks

Secondary Outcomes (1)

• Correlative Biomarkers

  Up to 14 weeks

Study Arms (1)

Scans, Surgical Resection and Assessment

EXPERIMENTAL

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; Procedure: Surgical Resection

Interventions

Pimonidazole 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.

Also known as: HydroxyProbe, Pimonidazole HCI

Scans, Surgical Resection and Assessment

Surgical Resection 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.

Also known as: Whipple Procedure, Pancreatoduodenectomy, Surgery

Scans, Surgical Resection and Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Varian Medical Systems: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

pimonidazole; Pancreaticoduodenectomy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures

Study Officials

• Sarah Hoffe, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 24, 2018
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

US (1)