RECRUITING

NearWave Optical Molecular Monitoring

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Conditions

Breast CancerHER2-positive Breast CancerTNBC - Triple-Negative Breast CancerHER2-negative Breast CancerInvasive Breast Carcinomaneoadjuvant chemotherapyimagingNearWaveinvasive breast cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).

Official Title

NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients

Quick Facts

Study Start:2025-03
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06744465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women ≥ 18 years old at the time of informed consent
  2. 2. Ability to provide written informed consent and HIPAA authorization
  3. 3. Patients who:
  4. 1. have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER/PR negative or low (ER and PR ≤ 9%, weak staining)
  5. 2. with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm
  6. 3. are planned to receive neoadjuvant chemotherapy followed by surgery
  7. 4. Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit
  8. 5. Have a palpable breast mass as determined by a treating physician
  1. 1. Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)
  2. 2. Inflammatory breast cancer
  3. 3. Prior breast cancer requiring surgery or radiation in either breast
  4. 4. Pregnant or nursing due to changes in breast architecture
  5. 5. Patients with a BMI of ≥ 40, unless the lesion is near the surface (\<3 cm from the skin surface), based on diagnostic scan measurements
  6. 6. Patients with any tattoos on their breasts

Contacts and Locations

Study Contact

Tarah J Ballinger, MD
CONTACT
(317) 944-3553
tarahb@iu.edu
Xin Bryan, RN
CONTACT
317-312-2793
zhongx@iu.edu

Study Locations (Sites)

Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03
Study Completion Date2025-07

Study Record Updates

Study Start Date2025-03
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • neoadjuvant chemotherapy
  • breast cancer
  • imaging
  • NearWave
  • invasive breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer
  • HER2-positive Breast Cancer
  • TNBC - Triple-Negative Breast Cancer
  • HER2-negative Breast Cancer
  • Invasive Breast Carcinoma