NCT03718650

Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer: Establishing the Radiomic/Pathologic Foundation of Heterogeneity

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-04-01
• Completion: 2023-04-01
• First posted: 2018-10-24
• Last updated: 2021-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study