Uptake of [18F]F-Gln during PET/CT Scan in Patients with Primary or Metastatic Breast Cancer

Status: active

This phase I trial studies the uptake of [18F]F-Gln during a positron emission tomography (PET)/computed tomography (CT) scan in patients with primary breast cancer or breast cancer that has spread to other places in the body. Glutamine is an amino acid in the body that participates in cell growth and metabolism. Dysregulation of glutamine metabolism may be associated with several malignancies. [18F]F-Gln is a specialized investigational radioactive PET tracer used to image glutamine metabolism. Imaging [18F]F-Gln uptake in various cancers may help researchers better understand the biology of tumors and determine the best way to use imaging to help study new treatments.

Inclusion Criteria

Known or suspected primary or metastatic breast cancer
At least one lesion >= 1.5 cm that is seen on standard imaging (e.g. CT, magnetic resonance imaging [MRI], mammogram, ultrasound, fludeoxyglucose F-18 [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 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

PRIMARY OBJECTIVE:

I. Evaluate the kinetics and biodistribution of fluorine F 18 4-L-fluoroglutamine (2S,4R) ([18F]F-Gln) in primary and metastatic breast cancer.

SECONDARY OBJECTIVES:

I. Evaluate the safety of [18F]F-Gln.

II. Assess the association of [18F]F-Gln uptake measures with estrogen-receptor status, progesterone-receptor status, and human epidermal growth factor receptor 2 (HER2) status.

III. Assess the association of [18F]F-Gln uptake measures with tumor markers of glutamine metabolism, if tissue is available.

IV. Measure the metabolism of [18F]F-Gln in patient blood samples over time.

V. Evaluate change in [18F]F-Gln uptake measures after therapy compared to pre-treatment baseline.

OUTLINE:

Patients receive fluorine F 18 4-L-fluoroglutamine (2S,4R) intravenously (IV) and then undergo dynamic imaging via PET/CT over 60 minutes followed by up to 2 static skull-base to mid-thigh scans done at approximately 60 and 90 minutes after injection. Patients who are undergoing systemic therapy as part of their clinical treatment for breast cancer may optionally undergo a second PET/CT scan.

After completion of study, patients are followed up to 10 hours post fluorine F 18 4-L-fluoroglutamine (2S,4R) injection and then periodically thereafter.

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Uptake of [18F]F-Gln during PET/CT Scan in Patients with Primary or Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

United States

Pennsylvania

Philadelphia

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Uptake of [18F]F-Gln during PET/CT Scan in Patients with Primary or Metastatic Breast Cancer

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