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In Vivo PARP-1 Expression With 18F-FTT PET/CT in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03492164
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:

The investigators plan to enroll 30 evaluable patients with (1) a histological diagnosis of advanced pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16 weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to participate in a clinical trial that contains PARP inhibitor therapy and are anticipated to receive this treatment or (3) will receive PARP inhibitor therapy as part of their clinical care.

A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/computed tomography (PET/CT) scan will be done prior to the start of treatment with a PARP inhibitor.

PET/CT imaging will be used to evaluate PARP-1 expression in sites of pancreatic cancer using the investigational radiotracer [18F]FTT. This is an observational study in that [18F]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [18F]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria.

Patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of [18F]FTT. This procedure will be followed by a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of approximately 10 mCi (approximate range for most studies is anticipated to be 8-12 mCi) of [18F]FTT. Data will be collected to evaluate uptake of [18F]FTT in sites of pancreatic cancer, which will be compared with PARP-1 expression in tissue, when available.

All 30 evaluable patients are expected to start PARP inhibitor therapy following the [18F]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 24 patients (80%) will also undergo a second (optional) scan that will be performed approximately 3 weeks (± 1 week) after therapy has started. The second scan is obtained to evaluate whether the PARP inhibitor therapy decreases [18F]FTT uptake, which would suggest PARP blocking by the therapy.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: [18F]FluorThanatrace ([18F]FTT) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Pancreatic Cancer
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
[18F]FluorThanatrace ([18F]FTT)
1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one also known as [18F]FluorThanatrace or [18F]FTT is a positron emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo inhibition of the PARP-1 nuclear enzyme with positron emission tomography (PET/CT).
Drug: [18F]FluorThanatrace ([18F]FTT)
1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one also known as [18F]FluorThanatrace or [18F]FTT is a positron emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo inhibition of the PARP-1 nuclear enzyme with positron emission tomography (PET/CT).
Other Name: [18F] FTT




Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be ≥ 18 years of age.
  • Histologically proven pancreatic adenocarcinoma. .
  • Deemed to have achieved stability following ≥16 weeks of platinum based therapy, in the opinion of an investigator
  • Considered a candidate for PARP inhibitor therapy, with or without additional agents, either on a clinical trial or as part of clinical care.
  • Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

  • Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492164


Contacts
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Contact: Austin Pantel, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 190104
Contact: Austin Pantel, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Austin Pantel, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Austin Pantel, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03492164     History of Changes
Other Study ID Numbers: UPCC 42217
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action