RECRUITING

Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

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 trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed.

Official Title

Sentinel Lymph Node Biopsy in Ductal Cancer in Situ or Unclear Lesions of the Breast and How to Not do it. An Open-label, Phase 3, Randomised Controlled Trial. (SentiNot 2.0).

Quick Facts

Study Start:2020-03-01
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04722692

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. * Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than or equal to 20 mm on mammography and planned for breast conserving surgery or
  2. * Patients with a preoperative diagnosis of DCIS on core biopsy with a palpable mass on clinical examination or mass effect on radiology or
  3. * Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy or
  4. * Patients with a mammographic/ultrasound/MRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer or
  5. * Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a complex oncoplastic procedure or
  6. * Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a procedure that may compromise detection rate for a future SLND, such as, but not confined to: lesions in the upper outer quadrant or the axillary tail, removal of the nipple areola complex and so on or
  7. * The above mentioned categories with a preoperative diagnosis of pleomorphic Lobular Cancer in Situ (pLCIS), classic Lobular Neoplasia (LN) or Atypical Ductal Hyperplasia (ADH).
  1. * Intolerance/hypersensitivity to iron, dextran compounds or SPIO
  2. * An iron overload disease
  3. * Patient deprived of liberty or under guardianship
  4. * Pregnant or lactating patients

Contacts and Locations

Study Contact

Andreas Karakatsanis, PhD
CONTACT
+46765864826
andreas.karakatsanis@surgsci.uu.se
Fredrik Wärnberg, PhD
CONTACT
fredrik.warnberg@vgregion.se

Principal Investigator

Andreas Karakatsanis, PhD
PRINCIPAL_INVESTIGATOR
Uppsala University

Study Locations (Sites)

Baylor College Of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Uppsala University

  • Andreas Karakatsanis, PhD, PRINCIPAL_INVESTIGATOR, Uppsala 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 Date2020-03-01
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2020-03-01
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • Sentinel Lymph Node Dissection
  • DCIS; Ductal Cancer In situ of the breast
  • Breast cancer
  • Superparamagnetic Iron Oxide Nanoparticles
  • Sentinel Lymph Node
  • Risk reducing mastectomy

Additional Relevant MeSH Terms

  • DCIS
  • Breast Cancer
  • Breast Neoplasms
  • Sentinel Lymph Node