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New treatment option for Metastatic Lobular Breast Carcinoma
Official title [68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
ClinicalTrials.gov ID: NCT07020806
What this study is testing
What is [68Ga]Ga DOTA-5G?
[68Ga]Ga DOTA-5G is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for metastatic lobular breast carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- (Ability to understand and willingness to sign a written informed consent document.
- Men and women age ≥ 18 yrs
- Confirmed presence of metastatic/advanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1) or PERCIST
- Available archival tumor tissue
- Eastern Cooperative Oncology Group Performance Status ≤ 2
You likely can't join if
- Pregnant and lactating women
- Prisoners
- Concurrent malignancy of a different histology that could confound imaging interpretation.
- Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
See the full eligibility criteria
- (Ability to understand and willingness to sign a written informed consent document.
- Men and women age ≥ 18 yrs
- Confirmed presence of metastatic/advanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1) or PERCIST
- Available archival tumor tissue
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3,Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 8 g/dL.
- Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN), Total bilirubin ≤ 2 times ULN, eGFR \>60 mL/min/1.73m\ 2
- Anticipated life expectancy ≥ 3 months
- Able to remain motionless for up to 30-60 minutes per scan.
- Pregnant and lactating women
- Prisoners
- Concurrent malignancy of a different histology that could confound imaging interpretation.
- Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.