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Fluorine F 18 Fluorthanatrace PET/CT in Treating Participants With Primary or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT03604315
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in treating participants ovarian, fallopian tube, or primary peritoneal cancer that is primary or has come back. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in participants with ovarian, fallopian tube, or primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Fallopian Tube Carcinoma Ovarian Carcinoma Primary Peritoneal Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Solid Neoplasm Procedure: Computed Tomography Radiation: Fludeoxyglucose F-18 Radiation: Fluorine F 18 Fluorthanatrace Procedure: Positron Emission Tomography Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate fluorine F 18 fluorthanatrace ([18F]Fluorthanatrace) positron emission tomography/computed tomography (PET/CT) as an imaging biomarker of poly [ADP-ribose] polymerase (PARP)-1 activity in 3 cohorts of cancer patients: 1) ovarian, fallopian tube, primary peritoneal 2) breast cancer, and 3) non-ovarian, non-breast solid tumor.

SECONDARY OBJECTIVES:

I. Evaluate the safety of [18F]Fluorthanatrace. II. Correlate [18F]Fluorthanatrace uptake measures with BRCA mutation status. III. Correlate [18F]Fluorthanatrace uptake measures with poly [ADP-ribose] polymerase (PARP-1) activity in tumor tissue samples in patients who undergo biopsies.

IV. Evaluate change in [18F]Fluorthanatrace uptake measures after therapy.

OUTLINE:

Participants receive fluorodeoxyglucose (FDG) intravenously (IV) and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, participants receive fluorine F 18 fluorthanatrace IV and undergo fluorine F 18 fluorthanatrace ([18F]FTT) PET/CT over 1 hour.

After completion of study treatment, participants are followed up at 24 hours.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Treatment (FDG PET/CT, [18F]FTT PET/CT)
Participants receive FDG IV and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, participants receive fluorine F 18 fluorthanatrace IV and undergo [18F]FTT PET/CT over 1 hour.
Procedure: Computed Tomography
Undergo FDG PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Procedure: Computed Tomography
Undergo [18F]FTT PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Radiation: Fludeoxyglucose F-18
Given IV
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

Radiation: Fluorine F 18 Fluorthanatrace
Given IV
Other Names:
  • [18F]FluorThanatrace
  • [18F]FTT

Procedure: Positron Emission Tomography
Undergo FDG PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Procedure: Positron Emission Tomography
Undergo [18F]FTT PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography [ Time Frame: Up to 4 years ]
    Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and standard deviation (SD) across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 4 years ]
  2. BRCA mutation status [ Time Frame: Up to 4 years ]
    To determine any correlation with BRCA status, fluorine F 18 fluorthanatrace ([18F]FTT) uptake values (mean and SD) across patient and lesion (summing across lesions) will be summarized, by BRCA status group. Group difference will be tested using t-tests.

  3. PARP-1 activity in tumor tissue samples [ Time Frame: Up to 4 years ]
    Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and SD across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.

  4. Change in fluorine F 18 fluorthanatrace uptake measures after therapy [ Time Frame: Baseline up to 4 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:

  • 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) for women only.
  • At least one lesion >= 1.0 cm that is seen on standard imaging (e.g. computed tomography [CT], magnetic resonance imaging (MRI), ultrasound, fludeoxyglucose (FDG) PET/CT.

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.
  • 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): NCT03604315


Contacts
Contact: Lilie Lin 713-563-2300 lllin@mdanderson.org

Locations
United States, Texas
M D Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Lilie L. Lin    713-563-2300      
Principal Investigator: Lilie L. Lin         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lilie Lin M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03604315     History of Changes
Other Study ID Numbers: 2017-0319
NCI-2018-01137 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0319 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Fluorodeoxyglucose F18
Fluorides
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs