40 Participants Needed

[18F] F-GLN PET/CT Imaging for Breast Cancer

([18F]F-GLN Trial)

TE
ES
Overseen ByErin Schubert
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a new imaging agent, Fluoroglutamine ([18F]F-GLN), is absorbed by breast cancer tumors. As an observational study, it will not alter your current treatment plan. The researchers seek to gather data on image quality and the agent's effectiveness in highlighting breast cancer, particularly in tumors 1.5 cm or larger. Individuals diagnosed with breast cancer or those who suspect they have it and have a tumor visible on imaging scans may be suitable candidates. The trial also evaluates the safety of this imaging agent. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to benefit from this new imaging technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Since this is an observational study, it's likely you can continue your medications, but you should confirm with the study team.

What prior data suggests that [18F]F-GLN PET/CT imaging is safe for breast cancer patients?

Research shows that the imaging agent [18F]F-GLN is under testing for use in people with breast cancer. This agent aids PET/CT scans in detecting cancer activity. In earlier studies, [18F]F-GLN identified more cancer sites compared to the common imaging agent 18F-FDG.

While these studies are promising, [18F]F-GLN remains in the early stages of human testing, so detailed safety information is limited. As part of a Phase 1 study, the primary focus is on assessing its safety for people. So far, available studies have not reported major safety concerns.

As with any new treatment, further research is necessary to fully understand its safety. Trial participants will be closely monitored to address any side effects promptly.12345

Why are researchers excited about this trial?

Unlike the standard treatments for breast cancer, which typically involve surgery, chemotherapy, radiation, or hormone therapies, [18F]F-GLN is a novel imaging agent that offers a different approach. This agent is designed to provide a detailed view of how breast cancer tumors uptake glutamine, a nutrient that cancer cells often use for growth. Researchers are excited about [18F]F-GLN because it allows for a non-invasive way to assess tumor metabolism and potentially tailor treatments based on how a tumor processes glutamine. This could lead to more personalized and effective treatment strategies, offering a glimpse into the biology of the cancer that current standard treatments don't provide.

What evidence suggests that [18F]F-GLN PET/CT imaging is effective for breast cancer?

Research shows that a special imaging technique called Fluoroglutamine [18F]F-GLN PET/CT can help monitor glutamine levels in breast cancer cells. Cancer cells often use glutamine, a nutrient, to grow. This trial will evaluate the uptake of [18F]F-GLN in breast cancer, collecting pilot data to assess image quality and gather preliminary information on uptake measures. Studies have found that this imaging method can detect changes in glutamine levels within cells, which is crucial for different breast cancer types, such as estrogen-receptor-positive and triple-negative breast cancers. Although researchers are still studying [18F]F-GLN, it has shown promise in identifying cancer activity by highlighting glutamine usage in cancer cells. This could enhance understanding of tumor growth.14678

Who Is on the Research Team?

AP

Austin Pantel, MD

Principal Investigator

Instructor of Radiology

Are You a Good Fit for This Trial?

This trial is for adults with breast cancer who have at least one tumor that's 1.5 cm or larger, visible on standard imaging like CT, MRI, mammograms, etc. It's open to those with primary or metastatic breast cancer and requires participants to consent to its investigational nature. Pregnant or breastfeeding women and individuals unable to tolerate imaging procedures are excluded.

Inclusion Criteria

I have or might have breast cancer that has spread.
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
I have a tumor larger than 1.5 cm visible on an imaging test.

Exclusion Criteria

I don't have any health issues that a doctor thinks would make the study unsafe for me.
I am not pregnant or breastfeeding.
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo dynamic PET scanning and static scans post injection of [18F]F-GLN. Baseline FDG-PET/CT is also performed.

1 day
1 visit (in-person)

Optional Second Imaging

Some subjects may undergo a second [18F]F-GLN PET/CT and FDG-PET/CT to collect data on changes in uptake in response to therapy.

Varies

Follow-up

Participants are monitored for safety and effectiveness after imaging sessions.

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Fluoroglutamine [18F]F-GLN
Trial Overview [18F]F-GLN PET/CT scans are being tested in this observational study of up to 40 patients with different types of breast cancer. The scan involves an injection of [18F]F-GLN and aims to collect metabolism data and assess the uptake related to glutamine metabolism in tumors when tissue samples are available.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCERExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Citations

[18F] F-GLN by PET/​CT in Breast Cancer ...[18F] F-GLN by PET/CT in Breast Cancer. Official Title. Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer. Secondary IDs. Study Status.
[18F](2S,4R)4-Fluoroglutamine PET Detects Glutamine ...18 F 4F-Gln PET tracked cellular glutamine pool size in breast cancers with differential GLS activity and detected increases in cellular glutamine pool size ...
Dual-Tracer Imaging on a Long–Axial-Field-of-View PETWith [18F]FGln signal correction, whole-tumor Ki increased to 0.0157 mL/min/cm3 (difference of 9%). mfEVolve's multitracer methodology showed ...
[18F] F-GLN by PET/CT in Breast Cancer | MedPathPatients 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.
[18F] F-GLN PET/CT Imaging for Breast Cancer... Fluoroglutamine [18F]F-GLN will have tolerable side effects & efficacy for patients with Breast Cancer and Breast Cancer. See if you qualify today!
Investigator's Brochure [18F] 4-L-Glutamine (2S,4R)In this preliminary clinical study, 18F-. FGln/PET detected more lesions in breast cancer patients than 18F-FDG/PET (90%vs. 80%). 5. A phase I ...
Kinetic Modeling of 18F-(2S,4R)4-Fluoroglutamine in Mouse ...In this paper, we model the kinetics of 18F-Gln observed in 2 breast cancer xenografts in mice, using both graphical and compartmental analyses ...
[18F](2S,4R)4-Fluoroglutamine PET Detects Glutamine Pool ...These findings reveal the utility of a noninvasive PET imaging method to monitor pharmacodynamic responses to cancer drugs that target glutamine breakdown.
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