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JOURNAL ONKOLOGIE – STUDIE

Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

Rekrutierend

NCT-Nummer:
NCT03463954

Studienbeginn:
August 2023

Letztes Update:
02.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Novian Health Inc.

Collaborator:
-

Studienleiter

John Lewin, MD
Principal Investigator
Yale University

Kontakt

Studienlocations
(3 von 10)

St. Elisabeth-Krankenhaus Köln-Hohenlind
50935 Cologne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Heidelberg University Hospital
69120 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Walter Reed National Military Medical Center
20889 Bethesda
United StatesRekrutierend» Google-Maps
University Hospital Zurich
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Subjects with biopsy-diagnosed malignant breast tumors less than or equal to 15 mm will be

invited to participate. Subjects will receive a screening MRI and if eligible will then have

laser ablation, followed by MRI and an excision at 4-6 weeks following the laser procedure.

This study will be deemed successful if the lower limit of a 95% confidence interval for the

proportion of patients who have complete tumor ablation with one Novilase laser ablation

procedure at 4-6 weeks post-procedure is greater than the performance goal. Specifically,

Novilase will have demonstrated success if the complete tumor ablation rate is greater than

87.85%.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Females, aged 18 years and older

- Able to give written informed consent herself

- Definitive pathologic diagnosis by needle core biopsy

- Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest

dimension and measures at least 5 mm away from the skin and chest wall, or can be

moved at least 5 mm away from the skin and chest wall by injection of saline or local

anesthetic

- No more than 10 mm of calcifications confined to the tumor on imaging

- Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable

to image-guidance therapy (i.e., a tumor which is well visualized through imaging can

be identified from surrounding breast tissue and does not have margins obscured by

other structures or artifacts on the images)

- Tumor is well visualized on MRI

- Subject with mammographic appearance of overall dense parenchymal tissue may be

included, as long as a clearly evident marker is present at tumor site

- Tumor with less than 25% intraductal component, as determined by core biopsy

- No clinically significant co-morbidities (e.g., chronic illnesses existing

simultaneously with and usually independent of breast cancer) that affect life

expectancy

- Subject weight limited to ≤300 lbs. or ≤136 kg

- Subject agrees to comply with standard of care radiation or adjuvant therapy as

prescribed by physician

Exclusion Criteria:

- Subject younger than 18 years of age

- Pregnant or breast-feeding

- Tumor poorly visualized by ultrasound or x-ray mammography imaging

- Contraindications to administration of gadolinium-based contrast agent, including:

prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stage

kidney disease, and/or acute or chronic severe renal insufficiency (Glomerular

filtration rate (GFR) <30ml/min/1.73 sq. meters)

- Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker,

metallic implants)

- History of severe asthma

- Tumor measuring greater than 15 mm in longest dimension

- Microcalcifications that extend beyond target tumor such that overall longest

dimension of target tumor and calcifications is longer than 15 mm.

- Advanced stage breast cancer

- Tumors that are lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phyllodes

tumor, or Paget's disease

- Tumor with only DCIS with microinvasion

- Extensive intraductal component in lesion (i.e., >25%) as determined by core biopsy

- Subject who is known to be BRCA positive

- Tumor that is ER/PR/HER2 negative (TNBC)

- Inability to lie in prone or supine position for one hour

- Subject who is currently participating in another investigational treatment, device or

drug study through follow up that would interfere with this trial

- Subject without a definitive HER2 test according to ASCO/CAP guidelines

Studien-Rationale

Primary outcome:

1. Percentage of target tumors completely ablated in one procedure (Time Frame - 4-6 weeks):
Efficacy: Rate of complete ablation by Novilase laser ablation

2. Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery (Time Frame - 4-6 weeks):
Safety: frequency of AEs

Secondary outcome:

1. Patient reported rate of return to activities of daily living post-laser ablation and post-surgery (Time Frame - 4-6 weeks):
Rate of recovery

2. Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks) (Time Frame - 4-6 weeks):
Post-procedure cosmetic satisfaction

3. Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery) (Time Frame - 4-6 weeks):
Health-related quality of life outcome measures

Geprüfte Regime

  • Novilase Laser ablation:
    Image-guided, percutaneous laser ablation of breast tumors

Quelle: ClinicalTrials.gov


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