Breast CancerNCT02037269
LightPathTM Imaging System for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens
An observational study of Breast Cancer, run by Lightpoint Medical Limited at 1 site in United Kingdom.
Trial summary
This study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using the LightPathTM Imaging System. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Jul 2016
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients ≥30 years of age with known breast cancer scheduled for breast-conserving surgery (BCS) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)
Who may be able to join
- Females ≥30 years of age with a diagnosis of invasive breast cancer or DCIS
- Scheduled for BCS +/- SLNB or ALND
- Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilisation, or must give history of no menses in past twelve months
Who cannot join
- Surgery or radiotherapy in the operated breast in the past 2 years
- Neoadjuvant systemic therapy
- Patients not suitable for BCS
- Blood glucose level ≥ 12 mmol/l on the day of surgery
- Known hypersensitivity to 18F-FDG
- Any patient who is pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Cerenkov Luminescence Imaging for Measuring Margin and Lymph Node Status in Breast Cancer Surgical Specimens
This study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using the LightPathTM Imaging System. The LightPathTM Imaging System which consists of a light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera. This study will measure the correlation between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical practice.
Read the detailed description
Subject's blood glucose level will be measured on the day of surgery. Subjects with a blood glucose level < 12 mmol/l receive an intravenous injection of 5 MBq/kg, up to a maximum 300 MBq of 18F-fluorodeoxyglucose (18F-FDG) prior to surgery. Breast cancer surgery will be performed per standard of care. SLNB will be performed using a dose of 150 MBq technetium 99 (99mTc) nanocolloid and patent blue dye. The resected WLE specimen and lymph nodes will be imaged in the LightPathTM Imaging System. A member of the research team who is not the operating surgeon will capture LightPathTM images intra-operatively.
Prior to CLI, the WLE specimen will be placed in a specimen holder. CLI is performed according to the LightPathTM Imaging System instructions for use. All CLI will be performed between 1 and 3 hours post injection of 18F-FDG.
The WLE specimen will then undergo standard of care histopathological analysis with a positive margin defined as either invasive carcinoma or ductal carcinoma in situ (DCIS) within 2mm of the specimen surface. Lymph nodes will also be examined according to standard of care histopathological analysis.
The CLI results will not be used to influence any surgical or clinical decision-making.
All staff in the operating theatre and the recovery area caring for the patient, and pathology staff processing surgical specimens will wear badge dosimeters. Staff handling surgical specimens will also wear ring dosimeters.
- Conditions
- Breast Cancer
- Keywords
- Cerenkov Luminescence Imaging, CLI, margin status
- Medical subject headings
- Breast Neoplasms
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 |
|---|---|---|
| All participants | Female patients ≥30 years of age with known breast cancer scheduled for breast-conserving surgery (BCS) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour margin status of the Wide Local Excision specimen as determined by the LightPathTM Imaging System
Measured: Intra-operative
Secondary outcomes (3)
Metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System
Measured: Intra-operative
Radiation dosimetry to operating theatre, recovery area and pathology staff
Measured: Up to 24 hours after injection of radiopharmaceutical
Ease of use of the LightPathTM Imaging System
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lightpoint Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anand D Purushotham, MBBS FRCS MD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037269
- Sponsor's protocol ID
- LPM-001
- Status last verified
- Aug 2016
- First submitted
- 14 Jan 2014
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Grootendorst MR, Cariati M, Pinder SE, Kothari A, Douek M, Kovacs T, Hamed H, Pawa A, Nimmo F, Owen J, Ramalingam V, Sethi S, Mistry S, Vyas K, Tuch DS, Britten A, Van Hemelrijck M, Cook GJ, Sibley-Allen C, Allen S, Purushotham A. Intraoperative Assessment of Tumor Resection Margins in Breast-Conserving Surgery Using 18F-FDG Cerenkov Luminescence Imaging: A First-in-Human Feasibility Study. J Nucl Med. 2017 Jun;58(6):891-898. doi: 10.2967/jnumed.116.181032. Epub 2016 Dec 8.
PubMed 27932562
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Cerenkov Luminescence Imaging for Measuring Margin and Lymph Node Status in Breast Cancer Surgical Specimens
- ClinicalTrials.gov ID
- NCT02037269
- Acronym / sponsor ID
- LPM-001
- Conditions
- Breast Cancer
- Keywords
- Cerenkov Luminescence Imaging, CLI, margin status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lightpoint Medical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College London
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jan 2014 (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.
This study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using the LightPathTM Imaging System. The LightPathTM Imaging System which consists of a light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera. This study will measure the correlation between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical practice.
Detailed description
Subject's blood glucose level will be measured on the day of surgery. Subjects with a blood glucose level < 12 mmol/l receive an intravenous injection of 5 MBq/kg, up to a maximum 300 MBq of 18F-fluorodeoxyglucose (18F-FDG) prior to surgery. Breast cancer surgery will be performed per standard of care. SLNB will be performed using a dose of 150 MBq technetium 99 (99mTc) nanocolloid and patent blue dye. The resected WLE specimen and lymph nodes will be imaged in the LightPathTM Imaging System. A member of the research team who is not the operating surgeon will capture LightPathTM images intra-operatively.
Prior to CLI, the WLE specimen will be placed in a specimen holder. CLI is performed according to the LightPathTM Imaging System instructions for use. All CLI will be performed between 1 and 3 hours post injection of 18F-FDG.
The WLE specimen will then undergo standard of care histopathological analysis with a positive margin defined as either invasive carcinoma or ductal carcinoma in situ (DCIS) within 2mm of the specimen surface. Lymph nodes will also be examined according to standard of care histopathological analysis.
The CLI results will not be used to influence any surgical or clinical decision-making.
All staff in the operating theatre and the recovery area caring for the patient, and pathology staff processing surgical specimens will wear badge dosimeters. Staff handling surgical specimens will also wear ring dosimeters.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | –Female patients ≥30 years of age with known breast cancer scheduled for breast-conserving surgery (BCS) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients ≥30 years of age with known breast cancer scheduled for breast-conserving surgery (BCS) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)
Key inclusion criteria (3 listed)
- Females ≥30 years of age with a diagnosis of invasive breast cancer or DCIS
- Scheduled for BCS +/- SLNB or ALND
- Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilisation, or must give history of no menses in past twelve months
Key exclusion criteria (6 listed)
- Surgery or radiotherapy in the operated breast in the past 2 years
- Neoadjuvant systemic therapy
- Patients not suitable for BCS
- Blood glucose level ≥ 12 mmol/l on the day of surgery
- Known hypersensitivity to 18F-FDG
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
Tumour margin status of the Wide Local Excision specimen as determined by the LightPathTM Imaging System
Time frame: Intra-operative
3 secondary outcomes
Metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System
Time frame: Intra-operative
Radiation dosimetry to operating theatre, recovery area and pathology staff
Time frame: Up to 24 hours after injection of radiopharmaceutical
Ease of use of the LightPathTM Imaging System
Time frame: Intra-operative
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 10 Aug 2016.
- Derived from this study: PubMed 27932562Grootendorst MR, Cariati M, Pinder SE, Kothari A, Douek M, Kovacs T, Hamed H, Pawa A, Nimmo F, Owen J, Ramalingam V, Sethi S, Mistry S, Vyas K, Tuch DS, Britten A, Van Hemelrijck M, Cook GJ, Sibley-Allen C, Allen S, Purushotham A. Intraoperative Assessment of Tumor Resection Margins in Breast-Conserving Surgery Using 18F-FDG Cerenkov Luminescence Imaging: A First-in-Human Feasibility Study. J Nucl Med. 2017 Jun;58(6):891-898. doi: 10.2967/jnumed.116.181032. Epub 2016 Dec 8.
- Sponsor websiteLink provided by the sponsor.
- Study site web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Anand D Purushotham, MBBS FRCS MD principal investigator
King's College London
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 Lightpoint Medical Limited at 1 site in United Kingdom.
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 3 inclusion and 6 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 10 Aug 2016. 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 Kingdom. 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?
Tumour margin status of the Wide Local Excision specimen as determined by the LightPathTM Imaging System (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02037269, which also lists 1 linked publication.
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 Aug 2016.