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Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT

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ClinicalTrials.gov Identifier: NCT02637934
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE December 18, 2015
First Posted Date  ICMJE December 22, 2015
Last Update Posted Date September 14, 2020
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
Number of Adverse Events [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Official Title  ICMJE Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Brief Summary Up to 30 women with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer will participate in two different imaging cohorts. The Biodistribution cohort will include up to 10 patients and the Dynamic cohort will include up to 20 patients. Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date will evaluate preliminary information on uptake of [18F]FTT in gynecological cancer and compare with PARP-1 activity in tissue.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Intervention  ICMJE
  • Drug: [18F]FluorThanatrace
  • Radiation: PET/CT imaging sessions
Study Arms  ICMJE
  • Experimental: Biodistribution
    The Biodistribution cohort will include up to 10 patients who will undergo a series of vertex to mid-thigh biodistribution [18F]FTT PET/CT scans over a period of approximately 4 hours.
    Interventions:
    • Drug: [18F]FluorThanatrace
    • Radiation: PET/CT imaging sessions
  • Experimental: Dynamic
    The Dynamic cohort will include up to 20 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh scans imaging post injection of [18F]FTT.
    Interventions:
    • Drug: [18F]FluorThanatrace
    • Radiation: PET/CT imaging sessions
Publications * Makvandi M, Pantel A, Schwartz L, Schubert E, Xu K, Hsieh CJ, Hou C, Kim H, Weng CC, Winters H, Doot R, Farwell MD, Pryma DA, Greenberg RA, Mankoff DA, Simpkins F, Mach RH, Lin LL. A PET imaging agent for evaluating PARP-1 expression in ovarian cancer. J Clin Invest. 2018 May 1;128(5):2116-2126. doi: 10.1172/JCI97992. Epub 2018 Apr 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Biodistribution cohort

  • Participants will be ≥ 18 years of age
  • History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or metastatic cancer at the time of study enrollment)
  • At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, ultrasound, FDG PET/CT)
  • Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria for Biodistribution cohort

  • 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
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Inclusion Criteria for Dynamic cohort

  • Participants will be ≥ 18 years of age
  • History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or recurrent cancer at the time of study enrollment)
  • At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, ultrasound, FDG PET/CT)
  • Clinical plan for biopsy or surgical procedure of at least one site of known or suspected cancer
  • Willing to consent to collection of pathology tissue for the purposes of research at the time of clinical biopsy or surgical procedure.
  • Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria for Dynamic cohort

  • 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.
  • No clinical plan for biopsy or surgical procedure of known or suspected cancer
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fiona Simpkins, MD 855-216-0098 PennCancerTrials@emergingmed.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02637934
Other Study ID Numbers  ICMJE UPCC 18815
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor  ICMJE Abramson Cancer Center of the University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fiona Simpkins, MD Abramson Cancer Center of the University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP