Precancerous ConditionNCT00807404
Optical Coherence Tomography in Tissue Samples From Women Undergoing Mastectomy for the Treatment or Prevention of Breast Ductal Intraepithelial Neoplasia
A study testing histopathologic examination and optical coherence tomography in people with Precancerous Condition, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells. PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Precancerous Condition
- What is being tested?
- histopathologic examination and optical coherence tomography
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Mar 2009
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Undergoing mastectomy at the City of Hope Breast Center for the treatment or prevention of breast ductal intraepithelial neoplasia
PATIENT CHARACTERISTICS:
- Fertile and/or pregnant patients allowed
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Forward Image Guided Ductoscopy for Early Cancer Screening
RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells.
PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia.
Read the detailed description
OBJECTIVES:
- To design and construct a portable forward imaging optical coherence tomography (OCT) needle probe.
- To compare OCT imaging of ex-vivo breast tumor tissue sections with histology to form the basis of an image library for in-vivo work.
- To initiate development of an OCT needle probe that is capable of acquiring core biopsy samples.
OUTLINE: Breast tissue samples are obtained during mastectomy and analyzed ex-vivo by optical coherence tomography (OCT) and by histopathological examination. Once routine pathological evaluation and tissue sampling are completed, OCT imaging is performed using a portable forward imaging needle probe that is inserted through the ducts of the tissue sample. OCT images of the surface of the closest margin to the tumor (if present) as well as images of the duct(s) in the nipple areola complex (after dilation) are obtained. Images of a cross section of the tumor (after the sample has been sliced by the pathologist) are also obtained. The OCT images are then correlated with tissue histology. The images are used to create a correlation histology-OCT atlas for the evaluation of subsequent images and for future reference.
- Conditions
- Precancerous Condition
- Being tested
- histopathologic examination, optical coherence tomography
- Keywords
- ductal intraepithelial neoplasia
- Medical subject headings
- Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
histopathologic examinationProcedure or surgery
optical coherence tomographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Design of a portable forward imaging optical coherence tomography (OCT) needle probe
Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology
Development of an OCT needle probe that is capable of acquiring core biopsy samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startNov 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous ConditionStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- I. B. Paz, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807404
- Sponsor's protocol ID
- CDR0000628769
- Other IDs
- P30CA033572, CHNMC-06008
- Status last verified
- May 2010
- First submitted
- 10 Dec 2008
- Last updated
- 27 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forward Image Guided Ductoscopy for Early Cancer Screening
- ClinicalTrials.gov ID
- NCT00807404
- Acronym / sponsor ID
- CDR0000628769
- Conditions
- Precancerous Condition
- Keywords
- ductal intraepithelial neoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Dec 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.
RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells.
PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia.
Detailed description
OBJECTIVES:
- To design and construct a portable forward imaging optical coherence tomography (OCT) needle probe.
- To compare OCT imaging of ex-vivo breast tumor tissue sections with histology to form the basis of an image library for in-vivo work.
- To initiate development of an OCT needle probe that is capable of acquiring core biopsy samples.
OUTLINE: Breast tissue samples are obtained during mastectomy and analyzed ex-vivo by optical coherence tomography (OCT) and by histopathological examination. Once routine pathological evaluation and tissue sampling are completed, OCT imaging is performed using a portable forward imaging needle probe that is inserted through the ducts of the tissue sample. OCT images of the surface of the closest margin to the tumor (if present) as well as images of the duct(s) in the nipple areola complex (after dilation) are obtained. Images of a cross section of the tumor (after the sample has been sliced by the pathologist) are also obtained. The OCT images are then correlated with tissue histology. The images are used to create a correlation histology-OCT atlas for the evaluation of subsequent images and for future reference.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| histopathologic examination | Procedure or surgery | – |
| optical coherence tomography | Procedure or surgery | – |
Primary outcome
Design of a portable forward imaging optical coherence tomography (OCT) needle probe
Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology
Development of an OCT needle probe that is capable of acquiring core biopsy samples
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 27 May 2010.
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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.
I. B. Paz, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing histopathologic examination and optical coherence tomography in people with Precancerous Condition, run by City of Hope Medical Center at 1 site 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?
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 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Design of a portable forward imaging optical coherence tomography (OCT) needle probe. The study lists 3 primary outcomes in all. 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 27 May 2010.