Breast CancerNCT00802932
Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Tx
An observational study of Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test metallic markers in the breast tissue after breast conserving surgery and to observe the metallic markers' stability in the breast for use as tumor bed markers and positioning devices for radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Non-contrast Computed Tomography (CT) Scans (Metallic Markers) and Non-contrast CT Scans (Metallic Markers)
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Research subjects will be recruited from the clinical practice of the Breast Program referred for radiation therapy at Moffitt Cancer Center who meets the eligibility criteria. This provides a potential pool of about 450 patients over a 12 month period.
Who may be able to join
- Pathologically confirmed stage 0, I or II bilateral or unilateral breast cancer
- Any invasive adenocarcinoma or intraductal carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Surgical treatment with lumpectomy (partial mastectomy)
- Successful placement of intraparenchymal metallic markers at last breast surgery
- Pathologic tumor size < 5.0 cm (Microscopic multifocality is allowed if total pathologic tumor size is within 5 cm)
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- Axillary sampling (sentinel node or axillary dissection) performed for axillary nodal staging for all invasive cancers. No axillary sampling is required for ductal carcinoma in situ)
- Negative margins of excision.
- Radiation treatment to begin within 8 weeks after last surgery or last dose of chemotherapy
- Negative post-biopsy mammogram if presented with mammographically detected microcalcifications to ensure removal of suspicious calcifications
- History of prior cancers is allowed if patient is without evidence of disease at the time of study entry
- Ability to understand and the willingness to sign written informed consent document
Who cannot join
- Pregnant or breast feeding at time of study entry. Note: Radiation therapy is teratogenic. Women of child bearing potential must agree to use adequate contraception (abstinence, hormonal or barrier method of birth control) prior to and during study participation. Should a woman become pregnant, she should inform the treating physicians immediately.
- Prior in-field irradiation
- Stage III or IV breast cancer
- Inability to place intraparenchymal metallic markers due to excessive bleeding or other intraoperative complication so that the surgeon deems it inadvisable to place the marker
- Pathologic tumor size >/= 5 cm
- Positive or unassessed margins of surgical resection
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- Diffuse calcifications on mammogram pre- or post-operatively
- Positive or suspicious post-lumpectomy mammogram or breast magnetic resonance imaging (MRI)
- Multicentric carcinoma in more than one quadrant of the breast
- Non-epithelial breast malignancy; Paget's disease of the nipple
- Personal history of collagen vascular disease clinically judged to be a contraindication to radiation therapy
- Recurrent disease or prior history of ipsilateral breast cancer
- Psychiatric or addictive disorders that impair patient's voluntary ability to participate in informed consent or protocol procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, 33612
About this study
Official title: Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Treatment
The purpose of this study is to test metallic markers in the breast tissue after breast conserving surgery and to observe the metallic markers' stability in the breast for use as tumor bed markers and positioning devices for radiation treatment.
Read the detailed description
In order to validate metallic marker placement and stability, patients will have the internal metallic markers placed at the time of their last breast surgery (either lumpectomy or re-excision for margins) by the surgeon and are permanent. They will undergo routine 3D CT-based treatment planning and will receive routine radiation treatment to the whole breast or partial breast as determined by the treating physician. Daily images of the breast will be obtained throughout treatment using the online portal imaging system. These images will be analyzed for the daily position of the metallic markers and compared across the entire course of treatment to determine the stability of metallic markers placement and to assess their efficacy as positioning devices for image guided radiation therapy.
- Conditions
- Breast Cancer
- Being tested
- Non-contrast Computed Tomography (CT) Scans (Metallic Markers), Non-contrast CT Scans (Metallic Markers)
- Keywords
- breast cancer, female, metallic markers, image guided radiation therapy, IGRT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast Computed Tomography (CT) Scans (Metallic Markers)Device
Non-contrast CT Scans prior to start of radiation therapy, and during weeks 2, 4, 6.
Non-contrast CT Scans (Metallic Markers)Device
Non-contrast CT Scans prior to start of radiation therapy and on Day 5.
| Study group | Role | What they receive |
|---|---|---|
| Partial Breast Radiation | 1. Patients receiving Partial breast radiation Receives: Device: Non-contrast Computed Tomography (CT) Scans (Metallic Markers) | |
| Whole Breast Radiation | 2. Patients receiving whole breast radiation Receives: Device: Non-contrast CT Scans (Metallic Markers) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positional Stability of Metallic Markers in the Breast Parenchyma
To validate that intraparenchymal metallic markers placed in the breast tissue can be used as stable markers throughout a course of radiation treatment for daily image guided localization. Image Guided Radiation Therapy (IGRT) will be deemed feasible if the average shift in marker position results in deviations of up to 7 mm from the initial position.
Measured: Completion of planned radiation treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleanor Harris, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802932
- Sponsor's protocol ID
- MCC-15303
- Other IDs
- 106406
- Status last verified
- Jan 2013
- First submitted
- 4 Dec 2008
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT00802932
- Acronym / sponsor ID
- MCC-15303
- Conditions
- Breast Cancer
- Keywords
- breast cancer, female, metallic markers, image guided radiation therapy, IGRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 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.
The purpose of this study is to test metallic markers in the breast tissue after breast conserving surgery and to observe the metallic markers' stability in the breast for use as tumor bed markers and positioning devices for radiation treatment.
Detailed description
In order to validate metallic marker placement and stability, patients will have the internal metallic markers placed at the time of their last breast surgery (either lumpectomy or re-excision for margins) by the surgeon and are permanent. They will undergo routine 3D CT-based treatment planning and will receive routine radiation treatment to the whole breast or partial breast as determined by the treating physician. Daily images of the breast will be obtained throughout treatment using the online portal imaging system. These images will be analyzed for the daily position of the metallic markers and compared across the entire course of treatment to determine the stability of metallic markers placement and to assess their efficacy as positioning devices for image guided radiation therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Breast Radiation | – | Device: Non-contrast Computed Tomography (CT) Scans (Metallic Markers)1. Patients receiving Partial breast radiation |
| Whole Breast Radiation | – | Device: Non-contrast CT Scans (Metallic Markers)2. Patients receiving whole breast radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Research subjects will be recruited from the clinical practice of the Breast Program referred for radiation therapy at Moffitt Cancer Center who meets the eligibility criteria. This provides a potential pool of about 450 patients over a 12 month period.
Key inclusion criteria (12 listed)
- Pathologically confirmed stage 0, I or II bilateral or unilateral breast cancer
- Any invasive adenocarcinoma or intraductal carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Surgical treatment with lumpectomy (partial mastectomy)
- Successful placement of intraparenchymal metallic markers at last breast surgery
Key exclusion criteria (13 listed)
- Pregnant or breast feeding at time of study entry. Note: Radiation therapy is teratogenic. Women of child bearing potential must agree to use adequate contraception (abstinence, hormonal or barrier method of birth control) prior to and during study participation. Should a woman become pregnant, she should inform the treating physicians immediately.
- Prior in-field irradiation
- Stage III or IV breast cancer
- Inability to place intraparenchymal metallic markers due to excessive bleeding or other intraoperative complication so that the surgeon deems it inadvisable to place the marker
- Pathologic tumor size >/= 5 cm
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 |
|---|---|---|
| Non-contrast Computed Tomography (CT) Scans (Metallic Markers)Non-contrast CT Scans prior to start of radiation therapy, and during weeks 2, 4, 6. | Device | Partial Breast Radiation |
| Non-contrast CT Scans (Metallic Markers)Non-contrast CT Scans prior to start of radiation therapy and on Day 5. | Device | Whole Breast Radiation |
Primary outcome
Positional Stability of Metallic Markers in the Breast Parenchyma
Time frame: Completion of planned radiation treatment.
To validate that intraparenchymal metallic markers placed in the breast tissue can be used as stable markers throughout a course of radiation treatment for daily image guided localization. Image Guided Radiation Therapy (IGRT) will be deemed feasible if the average shift in marker position results in deviations of up to 7 mm from the initial position.
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 30 Jan 2013.
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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.
Eleanor Harris, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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?
The sponsor lists 12 inclusion and 13 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 30 Jan 2013. 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?
Positional Stability of Metallic Markers in the Breast Parenchyma (time frame: Completion of planned radiation treatment.). 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 30 Jan 2013.