Florham Park, NJNCT03463954Now EnrollingIRB Ready

Malignant Neoplasm of Breast Clinical Trial in Florham Park, NJ

Access cutting-edge malignant neoplasm of breast treatment through this clinical trial at a research site in Florham Park. Study-provided care at no cost to qualified participants.

Sponsored by Novian Health Inc.

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Expert Care in Florham Park

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related malignant neoplasm of breast treatment provided free

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Check if you qualify for this malignant neoplasm of breast clinical trial in Florham Park, NJ

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Why Participate?

  • No-Cost Study Care

  • Local to Florham Park

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Florham Park site if eligible
  4. 4Begin participation

About This Malignant Neoplasm of Breast Study in Florham Park

Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.

Sponsor: Novian Health Inc.

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Florham Park?

Yes, this clinical trial (NCT03463954) has an active research site in Florham Park, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Malignant Neoplasm of Breast Treatment Options in Florham Park, NJ

If you're searching for malignant neoplasm of breast treatment options in Florham Park, NJ, this clinical trial (NCT03463954) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Florham Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced malignant neoplasm of breast specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all malignant neoplasm of breast clinical trials near you to find additional studies recruiting in your area.

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