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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

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.

Condition or disease Intervention/treatment Phase
Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Drug: [18F]FluorThanatrace Radiation: PET/CT imaging sessions Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Study Start Date : December 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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.
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.
Drug: [18F]FluorThanatrace
Radiation: PET/CT imaging sessions



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:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02637934


Contacts
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Contact: Fiona Simpkins, 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, 19104
Contact: Fiona Simpkins, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Fiona Simpkins, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Fiona Simpkins, MD Abramson Cancer Center of the University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02637934    
Other Study ID Numbers: UPCC 18815
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020