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Trial record 3 of 69742 for:    cancer

[18F] F-GLN by PET/CT in Breast Cancer ([18F] F-GLN)

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ClinicalTrials.gov Identifier: NCT03863457
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

Patients with known or suspected primary or metastatic breast cancer with one lesion that is 1.5 cm in diameter or greater may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 30 evaluable subjects will participate in a single imaging cohort. Patients will be stratified by breast cancer subtype with prioritization to recruit at least 10 estrogen-receptor-expressing (ER+) and 10 triple-negative breast cancers (TNBC).

This is an observational study; [18F]F-GLN PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [18F]F-GLN PET/CT results, treatment decisions are made by the treating physicians based upon clinical criteria.

[18F]F-GLN PET/CT imaging sessions will include an injection of [18F]F-GLN. Metabolism data will be collected. Pilot data will be collected to evaluate image quality and collect preliminary information on the uptake of [18F]F-GLN in breast cancer. Uptake measures will be compared to tumor markers of glutamine metabolism, when tissue is available. The safety of [18F]F-GLN will also be evaluated in all subjects.


Condition or disease Intervention/treatment
Breast Cancer Drug: Fluoroglutamine [18F]F-GLN

Detailed Description:
Up to 30 patients will undergo approximately 60 minutes of dynamic PET scanning followed by up to 2 static skull-base to mid-thigh scans post injection of [18F] (2S,4R)4-fluoroglutamine ([18F]F-GLN). A baseline FDG-PET/CT will also be performed, either as a routine clinical staging/re-staging scan or as a research scan. If performed as a research scan, the scan may include an optional dynamic imaging session. Some subjects, who undergo systemic therapy as part of their clinical treatment, may also undergo an optional second [18F]F-GLN PET/CT to collect pilot data on the changes in [18F]F-GLN uptake in response to therapy. Subjects who undergo a second [18F]F-GLN PET/CT may have a second FDG-PET/CT, again either as a standard-of-care restaging study or as an optional research scan. The timing of the optional second PET scans will vary depending on the type of treatment the subject is receiving.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Glutamine


Intervention Details:
  • Drug: Fluoroglutamine [18F]F-GLN
    Evaluate the kinetics and biodistribution of [18F]F-GLN in primary and metastatic breast cancer.
    Other Name: [18F](2S, 4R)4-Fluoroglutamine ([18F]F-GLN)


Primary Outcome Measures :
  1. Kinetics and Biodistribution of [18F]F-GLN [ Time Frame: 3 years ]
    Evaluate the biodistribution of [18F]F-GLN by measuring organ and whole body dosimetry.


Secondary Outcome Measures :
  1. Incidence of Adverse Events (Safety and Tolerability) [ Time Frame: 3 years ]
    Evaluate the safety of [18F]F-GLN. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  2. Association of Uptake with [18F]F-GLN [ Time Frame: 3 years ]
    Assess the correlation of [18F]F-GLN with pathologic sub-types of breast cancer using standard pathology results, ER, PR, HER2.

  3. Association with Tumor Markers and [18F]F-GLN [ Time Frame: 3 years ]
    Correlate uptake of [18F]F-GLN with pathologic measurement of glutamine metabolism in tissue.

  4. Metabolism of [18F]F-GLN [ Time Frame: 3 years ]
    Measure the biometabolites in patient blood over time, following injection of [18F]F-GLN to determine the rate at which [18F]F-GLN is metabolized.

  5. Change in Uptake of [18F]F-GLN After Therapy [ Time Frame: 3 years ]
    Evaluate change in [18F]F-GLN uptake measures after therapy compared to pre-treatment baseline.


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 30 evaluable participants ≥ 18 years of age.
Criteria

Inclusion Criteria:

  • Participants will be ≥ 18 years of age
  • Known or suspected primary or metastatic breast cancer.
  • At least one lesion ≥ 1.5 cm that is seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT). Only one type of imaging is required to show a lesion.
  • 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:

  • Females who are pregnant or breast feeding at the time of screening; 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): NCT03863457


Contacts
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Contact: Theresa E Berger, MBE 215-746-2813 theresa.berger@uphs.upenn.edu
Contact: Erin Schubert 215-573-6569 erin.schubert@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Theresa E Berger, MBE    215-746-2813    theresa.berger@uphs.upenn.edu   
Contact: Erin Schubert    215-573-6569    erin.schubert@uphs.upenn.edu   
Principal Investigator: Austin Pantel, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Austin Pantel, MD Instructor of Radiology

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03863457     History of Changes
Other Study ID Numbers: 831804
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University of Pennsylvania:
breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases