Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03718650
• Other study ID #: MCC-19599
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: April 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2021
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Resectable Pancreatic Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 14 weeks

External Links

•   Moffitt Cancer Center Clinical Trials Website