Imaged Breast AbnormalitiesI-PETNCT00720642
Percutaneous Excision Trial
An observational study of Imaged Breast Abnormalities, run by Intact Medical Corporation at 24 sites in United States.
Trial summary
To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Imaged Breast Abnormalities
- How many people
- 1,170 participants
- Where
- 24 sitesUnited States
- Study dates
- Jul 2006to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with an imaged breast abnormality found with mammography or sonography whose initial biopsy will be taken with the Intact BLES.
Who may be able to join
- Patient must be a female at least 18 years of age at the time of Intact BLES biopsy
- Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis
Who cannot join
- Patients who have pre-pectoral breast implants
- Patients who have implantable devices such as pacemakers and defibrillators
- Patients who are pregnant or lactating
- Patients in whom the device is contraindicated
- Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Lourdes Hospital Breast Center
Binghamton, New York, 13905
Jewish Hospital Breast Center
Cincinnati, Ohio, 45236
University of Cincinnati The Barrett Center
Cincinnati, Ohio, 45267-0772
Elyria Memorial Hospital
Elyria, Ohio, 44035
Genesys Medical Center
Grand Blanc, Michigan, 48439
The Breast Health Center
Indio, California, 92201
Wilson Hospital Breast Center
Johnson City, New York, 13790
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Evangelical Hospital
Lewisburg, Pennsylvania, 17837
Metro Surgical Associates, Inc.
Lithonia, Georgia, 30058
University of Arkansas for Medical Services
Little Rock, Arkansas, 72205
Long Beach Memorial Breast Center
Long Beach, California, 90806
Coastal Carolina Breast Center
Murrells Inlet, South Carolina, 29576
Nashville Breast Center
Nashville, Tennessee, 37205
Shawnee Mission Medical Center
Overland Park, Kansas, 66204
The Hill Breast Center
Pasadena, California, 91105
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Flagler Hospital
Saint Augustine, Florida, 32086
Mercy Medical Center
Springfield, Massachusetts, 01102
TIFT Regionald Medical Center
Tifton, Georgia, 31793
St. Joseph Medical Center
Towson, Maryland, 21204
Maui Medical Group
Wailuku, Hawaii, 96793
Center for Breast Care HCA
West Palm Beach, Florida, 33407
St. John West Shore Hospital
Westlake, Ohio, 44145
About this study
Official title: Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.
To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.
- Conditions
- Imaged Breast Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSAP | This is the population of patients in whom surgical intervention could possibly be avoided. These patients will be those in whom all imaging evidence (mammographic or sonographic) was removed during the Intact BLES procedure, and in whom a definitive diagnosis of ADH could be made using the pathology assessment criteria outlined in the protocol. | |
| NPSAP | Patients with a pathology diagnosis of ADH in whom all imaging evidence (mammographic or sonographic) of the target lesion was NOT removed OR in whom a definitive diagnosis of ADH COULD NOT be made by implementing the pathology criteria for evaluation outlined in the protocol AND patients with a diagnosis of DCIS will undergo open surgical excision and will be analyzed separately from the PSAP group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision.
Measured: Post Intact Excision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJul 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imaged Breast AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intact Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720642
- Sponsor's protocol ID
- Intact 06-06
- Acronym
- I-PET
- Status last verified
- Sep 2012
- First submitted
- 21 Jul 2008
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.
- ClinicalTrials.gov ID
- NCT00720642
- Acronym / sponsor ID
- I-PET / Intact 06-06
- Conditions
- Imaged Breast Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,170 participants (actual)
- Lead sponsor
- Intact Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSAP | – | –This is the population of patients in whom surgical intervention could possibly be avoided. These patients will be those in whom all imaging evidence (mammographic or sonographic) was removed during the Intact BLES procedure, and in whom a definitive diagnosis of ADH could be made using the pathology assessment criteria outlined in the protocol. |
| NPSAP | – | –Patients with a pathology diagnosis of ADH in whom all imaging evidence (mammographic or sonographic) of the target lesion was NOT removed OR in whom a definitive diagnosis of ADH COULD NOT be made by implementing the pathology criteria for evaluation outlined in the protocol AND patients with a diagnosis of DCIS will undergo open surgical excision and will be analyzed separately from the PSAP group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an imaged breast abnormality found with mammography or sonography whose initial biopsy will be taken with the Intact BLES.
Key inclusion criteria (2 listed)
- Patient must be a female at least 18 years of age at the time of Intact BLES biopsy
- Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis
Key exclusion criteria (5 listed)
- Patients who have pre-pectoral breast implants
- Patients who have implantable devices such as pacemakers and defibrillators
- Patients who are pregnant or lactating
- Patients in whom the device is contraindicated
- Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision.
Time frame: Post Intact Excision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Imaged Breast Abnormalities, run by Intact Medical Corporation at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision. (time frame: Post Intact Excision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2012.