Breast CancerPhase 1/2NCT01614184
Fluorescein for Sentinel Lymph Node Biopsy (SLNB) in Breast Cancer
A Phase 1/2 study testing Fluorescein in people with Breast Cancer, run by University of Utah.
Trial summary
The study goal is to develop a new method of intraoperative lymphatic mapping with fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery. 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?
- Fluorescein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jun 2013
- Phase
- Phase 1/2
- 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
Who may be able to join
- Female patient
- Ability to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
- Between 18 and 90 years of age.
- Have been diagnosed with invasive adenocarcinoma, or high-grade ductal carcinoma in-situ. If a core or open biopsy is done, it must demonstrate invasive adenocarcinoma. If only a FNA is done, it must be positive and accompanied by a positive clinical breast examination and ultrasound or mammography. The tumor must be operable.
- Clinically negative lymph nodes.
- Must have had a bilateral mammogram within a year of enrollment.
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- The interval between the initial cytologic or histologic diagnosis of breast cancer and enrollment must be no more than 60 days.
- ECOG performance status 0-1
- Patients in whom the diagnosis of breast cancer has been obtained utilizing fine needle aspiration cytology or core needle biopsy are preferred. However, patients who are diagnosed by open biopsy procedures are eligible.
- Patients with prior excisional biopsy or lumpectomy are eligible for entry.
- Patients with prior non-breast malignancies are eligible if they have been disease free for 5 years before enrollment. Patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by operation only, or LCIS of the ipsilateral or contralateral breast treated by surgery only are eligible, even if these conditions were diagnosed within 5 years before enrollment onto this study.
Who cannot join
- Male patient
- Ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration. Patients with these latter to conditions are eligible.)
- One or more ipsilateral axillary lymph nodes that are positive for tumor on clinical examination.
- Bilateral malignancy or a mass in the opposite breast that is suspicious for malignancy, unless a biopsy proves that the mass is not malignant.
- Previous removal of any ipsilateral axillary lymph node.
- Diffuse tumors or multiple malignant tumors in different quadrants of the breast.
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- Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor.
- Patients with any prior breast malignancy other than LCIS.
- Prior treatment for this breast cancer including irradiation, chemotherapy, immunotherapy, and/or hormonal therapy.
- Allergy to radiocolloid or fluorescein.
- Inability to localize SLN drainage basins via lymphatic mapping. (e.g., no basin found which emits gamma-radiation after injection with technetium -99)
- Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol, or be exacerbated by therapy.
- Breast cancer related operative procedures not corresponding to criteria described in the protocol.
- Primary or secondary immune deficiencies or known significant autoimmune disease which would pose a risk to the participant based on the physician's judgment.
- History of organ transplantation.
- Pregnant or lactating women.
- Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial.
- Nonmalignant systemic disease (e.g., cardiovascular, renal, hepatic, etc.) that precludes a patient from being subjected to any of the treatment options or that would prevent prolonged follow-up based on the physician's judgment.
About this study
Official title: Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Operable Breast Cancer
The study goal is to develop a new method of intraoperative lymphatic mapping with fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery.
- Conditions
- Breast Cancer
- Being tested
- Fluorescein
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresceinDrug
Also called Fluorescite®
Fluorescite® (fluorescein injection, USP) 10% fluorescein sodium diluted to from 1% to 0.001% in sterile saline, 0.25 ml injected intradermally peri-tumoral or peri-areolar. A single dose regimen.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All patients enrolled in study. Receives: Drug: Fluorescein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel Lymph node (SLN) detection
Ability of peri-areolar or peri-tumoral fluorescein to detect SLNs in patients with operable breast cancer.
Measured: 36 months
Secondary outcomes (5)
Fluorescence detection
To evaluate the ability to detect fluorescein fluorescence transdermally with a fluorometer.
Measured: 36 months
Correlation between two radiation intensities
To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN ex-vivo gamma radiation intensity.
Measured: 36 months
Correlation between intensity and metastasis
To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN metastasis.
Measured: 36 months
Fluorescence detection after processing
To evaluate if fluorescein fluorescence can be detected in the SLN after fixation and histological processing.
Measured: 36 months
Number of patients with adverse events
To evaluate the safety of peri-areolar or peri-tumoral fluorescein injections.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMay 2008
- Primary completionJun 2013
- Study completionJun 2013
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.
- More trials run by University of UtahThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614184
- Sponsor's protocol ID
- HCI23922
- Status last verified
- Jul 2013
- First submitted
- 6 Mar 2012
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT01614184
- Acronym / sponsor ID
- HCI23922
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jun 2012 (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 study goal is to develop a new method of intraoperative lymphatic mapping with fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: FluoresceinAll patients enrolled in study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female patient
- Ability to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
- Between 18 and 90 years of age.
- Have been diagnosed with invasive adenocarcinoma, or high-grade ductal carcinoma in-situ. If a core or open biopsy is done, it must demonstrate invasive adenocarcinoma. If only a FNA is done, it must be positive and accompanied by a positive clinical breast examination and ultrasound or mammography. The tumor must be operable.
- Clinically negative lymph nodes.
Key exclusion criteria (18 listed)
- Male patient
- Ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration. Patients with these latter to conditions are eligible.)
- One or more ipsilateral axillary lymph nodes that are positive for tumor on clinical examination.
- Bilateral malignancy or a mass in the opposite breast that is suspicious for malignancy, unless a biopsy proves that the mass is not malignant.
- Previous removal of any ipsilateral axillary lymph node.
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 |
|---|---|---|
| FluoresceinAlso: Fluorescite®Fluorescite® (fluorescein injection, USP) 10% fluorescein sodium diluted to from 1% to 0.001% in sterile saline, 0.25 ml injected intradermally peri-tumoral or peri-areolar. A single dose regimen. | Drug | All patients |
Primary outcome
Sentinel Lymph node (SLN) detection
Time frame: 36 months
Ability of peri-areolar or peri-tumoral fluorescein to detect SLNs in patients with operable breast cancer.
5 secondary outcomes
Fluorescence detection
Time frame: 36 months
Correlation between two radiation intensities
Time frame: 36 months
Correlation between intensity and metastasis
Time frame: 36 months
Fluorescence detection after processing
Time frame: 36 months
Number of patients with adverse events
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fluorescein in people with Breast Cancer, run by University of Utah.
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 11 inclusion and 18 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: withdrawn, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sentinel Lymph node (SLN) detection (time frame: 36 months). 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 10 Jul 2013.