Bedömning av säkerheten, ultraljudsuppfattningen och migrationen av blinkande markörer hos patienter med lokalt avancerad bröstcancer som genomgår neoadjuvant systemisk terapi och kirurgi, UTMOST-prövning
En fas 1-studie på patienter med kliniskt nodpositiv bröstcancer för att bedöma säkerheten, ultraljudssynen och migreringen av en ultraljudsglimtmarkör som observerats för sonografisk inriktning (UTMOST TRIAL)
This phase I study assesses the safety, ultrasound visibility (conspicuity), and movement from normal position (migration) of the twinkling marker in patients with breast cancer that has spread to the axillary lymph nodes (locally advanced) who will be undergoing neoadjuvant systemic therapy and surgery. Biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are needed to help guide breast cancer surgery. Twinkling markers are designed to have the same size and shape of conventional biopsy markers, but are made of a radio-opaque material that assists with localization of the marker. The twinkling marker may make it more easily seen with ultrasound at the time of breast cancer surgery as compared to conventional biopsy markers.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVE:
I. To show that the biologically inert, Food and Drug Administration (FDA)-approved material that comprises the Mayo-developed twinkling marker, either pre-made and sterilized or made immediately before placement, (Patent Application Title: Non-Metallic Ultrasound-Detectable Markers Patent Application No.: 62/903,078, Application Type: Provisional) remains conspicuous under ultrasound after neoadjuvant systemic therapy in patients with clinically node-positive breast cancer.
SECONDARY OBJECTIVE:
I. To evaluate the safety and migration of the Mayo-designed twinkling marker in patients during neoadjuvant systemic therapy (NST).
OUTLINE:
Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker throughout the trial. Patients undergo a breast ultrasound during screening, on study, and as clinically indicated. Patient also undergoes a mammogram on study and as clinically indicated as well as a magnetic resonance imaging (MRI) as clinically indicated.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Locally advanced breast cancer patients undergoing neoadjuvant systemic therapy and surgery with Dr. Piltin at Mayo Clinic.
Beskrivning
Inclusion Criteria:
- Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- Surgical management will be determined by the surgeon, who will decide if preoperative I-125 seed localization of the positive node is necessary or if they will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and twinkling marker will be resected. The position of the marker in the lymph node or proximity to the node will be noted from the surgical and pathology documentation.
- Surgery will be performed by one of the surgeons in the Division of Breast and Melanoma Surgical Oncology (Dr. Judy Boughey, Dr. Amy Degnim, Dr. Tina Hieken, Dr. Jeffrey Johnson, Dr. Mary Mrdutt, Dr. Dalliah Black, Dr. Mara Piltin)
- Patients must be able to understand the study procedures and comply with them for the entire length of the study
- No contraception is necessary or required
Exclusion Criteria:
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
- Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Observational (twinkle marker placement)
Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker throughout the trial. Patients undergo a breast ultrasound during screening, on study, and as clinically indicated. Patient also undergoes a mammogram on study and as clinically indicated as well as a MRI as clinically indicated. |
Undergo MRI
Andra namn:
Undergo a mammogram Undergo a breast ultrasound Undergo a percutaneous ultrasound-guided breast clip placement
Andra namn:
Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker on study. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Long-term efficacy of the twinkling marker
Tidsram: through study completion, an average of 4 months
|
The primary outcome is information on the long-term efficacy of the twinkling marker in humans placed in the lymph nodes of patients undergoing neoadjuvant systemic therapy (NST) for breast cancer. The data will explore the presence/absence of the twinkling artifact associated with the twinkling marker under ultrasound. |
through study completion, an average of 4 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Determination of safety and migration of the twinkling marker
Tidsram: through study completion, an average of 4 months
|
The secondary outcome is determination of safety and migration of the Mayo-designed twinkling marker in patients after NST. Clinical notes will be reviewed to assess for any complications related to the twinkling marker during NST. Migration will be determined from surgical and pathology documentation. |
through study completion, an average of 4 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christine U Lee, M.D., Ph.D., Mayo Clinic in Rochester
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 22-002857
- DTP (Annan identifierare: Mayo Clinic Radiology)
Läkemedels- och apparatinformation, studiedokument
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