[68Ga]Ga DOTA-5G for Breast Cancer

Overseen By Julie Sutcliffe, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Prisoners, Concurrent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique using a compound called [68Ga]Ga DOTA-5G, a radiotracer for PET/CT scans, to better detect and understand metastatic invasive lobular breast cancer. The goal is to evaluate how effectively this imaging method identifies cancer spread. Participants will undergo a PET/CT scan following an injection of the compound. The trial seeks individuals diagnosed with metastatic invasive lobular breast cancer who have measurable disease and can remain still for up to an hour during the scan. 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 experience this innovative imaging method.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that [68Ga]Ga DOTA-5G is likely to be safe for humans?

A previous study found that both [68Ga]Ga DOTA-5G and a similar agent were well-tolerated, with no serious side effects linked to the drug. While this is encouraging, it is important to remember that this information comes from early research. Researchers are still studying this imaging agent to confirm its safety. Early trial phases mainly focus on checking safety, so limited information is available. However, initial findings suggest that [68Ga]Ga DOTA-5G could be safe for use in imaging. Always discuss any concerns with the study team or your doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for breast cancer, which generally focus on chemotherapy, hormone therapy, and targeted therapies, [68Ga]Ga DOTA-5G offers a unique approach by utilizing a novel PET/CT imaging technique. This method involves a new radiotracer, [68Ga]Ga DOTA-5G, which is designed to provide more precise imaging of cancer cells. Researchers are excited because this can potentially lead to better detection and monitoring of breast cancer, allowing for more personalized and effective treatment strategies. This innovative imaging approach could significantly enhance the ability to track tumor response and progression, offering a promising advancement in the management of breast cancer.

What evidence suggests that [68Ga]Ga DOTA-5G might be an effective treatment for breast cancer?

Research has shown that \[68Ga\]Ga DOTA-5G is being studied in this trial as a new method to image advanced breast cancer. Early results suggest that this technique, when combined with PET/CT scans, could aid in diagnosing metastatic or advanced invasive lobular breast cancer. Although detailed information on \[68Ga\]Ga DOTA-5G is limited, similar imaging agents, such as \[68Ga\]Ga-DOTATOC, have successfully detected breast tumors. This suggests that \[68Ga\]Ga DOTA-5G might also effectively identify cancer spread and assist doctors in planning treatments. ^{1 2 5 6 7}

Who Is on the Research Team?

Julie Sutcliffe, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for patients with advanced or metastatic invasive lobular breast cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a confirmed diagnosis of the condition being studied.

Inclusion Criteria

Hematologic parameters: ANC ≥ 1000 cells/mm3, Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 8 g/dL

I am 18 years old or older.

I can perform daily activities with minimal assistance.

Exclusion Criteria

Pregnant and lactating women

Patients who cannot undergo PET/CT scanning because of weight limits (>350lbs)

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive an injection of [68Ga]Ga DOTA-5G and undergo PET/CT scans to detect lesions

2 hours

1 visit (in-person)

Safety Monitoring

Participants are monitored for safety and tolerability of [68Ga]Ga DOTA-5G based on adverse events

7 days

Follow-up

Participants are monitored for any delayed adverse events and overall health status

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [68Ga]Ga DOTA-5G

Trial Overview [68Ga]Ga DOTA-5G is being tested as a diagnostic imaging agent in this study. Patients will undergo PET/CT scans using this agent to see how well it can identify and assess their cancer.

How Is the Trial Designed?

Group I: [68Ga]Ga-DOTA-5G PET/CT imaging Experimental Treatment 1 Intervention

Following an injection of up to 5 mCi of \[68Ga\]Ga DOTA-5G patients will be undergo PET/CT scans.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Dr. Cameron Foster, University of California Davis

Collaborator

Dr. Helen K Chew, University of California Davis

Collaborator

Society of Nuclear Medicine and Molecular Imaging

Collaborator

Trials

1

Recruited

40+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07020806

[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for ... This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).

2. cancer.gov cancer.gov/clinicaltrials/NCI-2025-04130

[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for ... Using [68Ga]Ga DOTA-5G as a diagnostic imaging agent with PET/CT may be safe and effective in diagnosing patients with metastatic or advanced invasive lobular ...

3. theranostictrials.org theranostictrials.org/studies/cl74bp9il0231ajjf2950vuef

Breast A Prospective Pilot Study to Explore Performance and Efficacy of 68Ga-FAPI PET/CT in Breast Cancer Patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5765332/

Evaluation of the Possible Utilization of 68Ga-DOTATOC in ... The results indicated the higher efficiency of 68Ga-DOTATOC in detecting breast tumors. The authors suggested the utilization of 68Ga-DOTATOC PET for the ...

5. lobularbreastcancer.org lobularbreastcancer.org/20502-2/

Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/ ... This is a phase I investigator-initiated study that will investigate [68Ga]Ga DOTA-5G in patients with metastatic/advanced invasive LBC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5362940/

Safety and Efficacy of 68Ga-DOTATATE PET/CT ... Our purpose was to evaluate safety and efficacy of 68 Ga-DOTATATE PET/CT compared with 111 In-pentetreotide imaging for diagnosis, staging, and restaging

7. jnm.snmjournals.org jnm.snmjournals.org/content/64/supplement_1/p1300

First-in-human study of the theranostic pair [68Ga]Ga DOTA ... Both the [68Ga]Ga DOTA-5Gand [177Lu]Lu DOTA-ABM-5G agents were well tolerated and no drug related serious adverse events have been observed. The [68Ga]Ga DOTA- ...