Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

Early Phase 1

Withdrawn

• Conditions: Resectable Pancreatic Cancer; Pancreatic Cancer
• Interventions: Drug: Pimonidazole; Procedure: Surgical Resection

• Registration Number: NCT03718650
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-08
• Study Start: 2021-04-01
• Primary Completion: 2022-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scans, Surgical Resection and Assessment	Surgical Resection	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).
Scans, Surgical Resection and Assessment	Pimonidazole	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).

Primary Outcome Measures

Name	Time	Method
Radiosensitivity Index and Degree of Pimonidazole Staining	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

Name	Time	Method
Correlative Biomarkers	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.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States