deltatrials
Completed NA INTERVENTIONAL 1-arm NCT01106521

A Registry Study of Permanent Breast Seed Implant

A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.

Sponsor: British Columbia Cancer Agency

Updated 7 times since 2017 Last updated: Oct 22, 2021 Started: Mar 31, 2009 Primary completion: Jan 19, 2018 Completion: Jan 19, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Breast Neoplasms, this trial is completed. The trial is conducted by British Columbia Cancer Agency and has accumulated 7 data snapshots since 2009. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy. Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.

For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.

Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotRecruiting~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotRecruiting~Jan 2021 – ~Nov 2021 · 10 months · monthly snapshotRecruiting~Nov 2021 – ~Jul 2024 · 32 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Nov 2021 — Jul 2024 [monthly]

    Completed NA

    Status: RecruitingCompleted

  5. Jan 2021 — Nov 2021 [monthly]

    Recruiting NA

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Recruiting NA

  2. Jan 2017 — Jun 2018 [monthly]

    Recruiting NA

    First recorded

Mar 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • British Columbia Cancer Agency
  • Sunnybrook Health Sciences Centre
  • West Penn Allegheny Health System
Data source: Sunnybrook Health Sciences Centre

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations