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Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

Primary Purpose

Pancreatic Cancer, Resectable Pancreatic Cancer

Status

Withdrawn

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pimonidazole

Surgical Resection

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scans, Surgical Resection and Assessment

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Correlative Biomarkers

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.

Full Information

NCT ID

NCT03718650

First Posted

October 23, 2018

Last Updated

February 3, 2021

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Varian Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT03718650

Brief Title

Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

April 1, 2021 (Anticipated)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Varian Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Resectable Pancreatic Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scans, Surgical Resection and Assessment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pimonidazole

Other Intervention Name(s)

HydroxyProbe, Pimonidazole HCI

Intervention Description

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

Procedure

Intervention Name(s)

Surgical Resection

Other Intervention Name(s)

Whipple Procedure, Pancreatoduodenectomy, Surgery

Intervention Description

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.

Primary Outcome Measure Information:

Title

Radiosensitivity Index and Degree of Pimonidazole Staining

Description

Time Frame

Up to 14 weeks

Secondary Outcome Measure Information:

Title

Correlative Biomarkers

Description

Time Frame

Up to 14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah Hoffe, MD

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

Links:

URL

http://moffitt.org/clinical-trials-research/clinical-trials/

Description

Moffitt Cancer Center Clinical Trials Website

Learn more about this trial

Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

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