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The LightPath® and 68Ga-RM2 in Breast Cancer Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731026
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Lightpoint Medical Limited

Tracking Information
First Submitted Date  ICMJE July 25, 2018
First Posted Date  ICMJE November 6, 2018
Last Update Posted Date November 6, 2018
Estimated Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Diagnostic performance of LightPath® Imaging System [ Time Frame: up to 5 year ]
Agreement between margin status determined by LightPath® Imaging and post-operative histopathology (Group 3)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Optimal scan time-window for 68Ga-RM2 PET/CT imaging [ Time Frame: 1 year ]
    Group 1 only
  • Gamma probe measurements (collimated) in the axilla to determine optimal 68Ga-RM2 activity [ Time Frame: 1 year ]
    Group 1 only
  • Value of 68Ga-RM2 PET/CT imaging for breast cancer staging [ Time Frame: 1 year ]
    Group 1 only
  • Radiation dosimetry measurements for the staff [ Time Frame: 1 year ]
    Group 1 only
  • Optimal device settings, tracer dose, and working procedures [ Time Frame: up to 2 years ]
    Group 2 only
  • Inter-rater agreement in post-operative standardised, controlled assessments of LightPath® Images [ Time Frame: up to 5 year ]
    Group 3 only
  • MDT decision to re-operate at index location [ Time Frame: up to 5 year ]
    Group 3 only
  • Weight of primary lump and lump plus shavings [ Time Frame: up to 5 year ]
    Groups 2 and 3 only
  • Radiation dosimetry for operating room and recovery area staff [ Time Frame: up to 5 year ]
    Groups 2 and 3 only
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2018)
  • Association between PET and/or LightPath® results and biomarkers (ER, PR, HER2, other according to local practice) [ Time Frame: up to 5 year ]
    Exploratory Outcome Measures
  • Study-related adverse events (AEs) [ Time Frame: up to 5 year ]
    Exploratory Outcome Measures
  • Lymph node involvement by LightPath® Image (compared with histology: macrometastasis, micrometastasis, or isolated tumour cells) [ Time Frame: up to 5 year ]
    Exploratory Outcome Measures
  • Agreement between 68Ga-RM2 and gastrin-releasing peptide receptor (GRPR) immunohistochemistry [ Time Frame: up to 5 year ]
    Exploratory Outcome Measures
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The LightPath® and 68Ga-RM2 in Breast Cancer Study
Official Title  ICMJE Evaluation of the LightPath® Imaging System and the PET Tracer 68Ga-RM2 in Wide Local Excision (WLE) for Breast Cancer
Brief Summary

This study is a prospective, open-label study to examine the performance of the LightPath® Imaging System using the PET tracer 68Ga-RM2 in patients scheduled for and/or undergoing wide local excision (WLE) with or without sentinel lymph node biopsy (SLNB) or complete axillary lymph node dissection(cALND) for breast cancer with an ER-positive invasive primary cancer.

The study consists of 3 sequential groups:

Group 1 (N=20 patients): Torso, i.e. base of skull to thighs, PET/CT imaging and axillary gamma probe measurements (using a collimator) of 68Ga-RM2 to: determine the optimal scan time-window post-injection; to extrapolate the optimal dose for resolution against axillary background signal on gamma probe measurements (first 6 patients); and the value of 68Ga-RM2 PET/CT imaging for breast cancer staging (all 20 patients).

Group 2 (N=10 patients): Intraoperative LightPath® imaging with 68Ga-RM2 to familiarise site with procedure and interpretation of intraoperative scans,validate the dose and timings determined from Group 1, and optimise LightPath® Imaging parameters such as acquisition resolution and duration. Group 2 scans will acquire LightPath® images of both intact and incised cancer specimens for post-operative standardised, controlled assessment. Group 2 will use the optimal scan time-window and 68Ga-RM2 activity extrapolated from at least the first 6 patients in Group 1. The dose of 68Ga-RM2 will be determined to optimise the intra-operative imaging and axillary gamma probe measurements.

Group 3 (N=50 patients): Intraoperative LightPath® imaging with 68Ga-RM2 to measure agreement between LightPath® images and post-operative histopathology. Group 3 scans will acquire LightPath® images of intact and incised cancer specimens for post-operative standardised, controlled assessment. Group 3 will use the optimal scan time-window and 68Ga-RM2 activity extrapolated from the first 6 patients in Group 1 with the optimised imaging parameters, and dose developed from Group 2.

The intraoperative LightPath® Images will be used to inform the surgeons about detectable residual cancer in an attempt to achieve better guided cancer surgery and complete tumour excision with clear WLE resection margins

The study site will use the local criteria considered standard of care to guide decisions to act on positive margins. Lightpoint Medical will provide guidance to act on LightPath® Images in the Instructions forUse (IFU). It will be at the Investigator's discretion to choose whether to act based upon the intraoperative LightPath® Images.

In Group 3,the resection margin status of the WLE specimen, cavity shavings (if any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the LightPath® Imaging System will be compared with histopathology results. A positive margin on histology will be defined as

  • Invasive carcinoma: positive: ink on tumour; close: <1mm; negative ≥1mm
  • Ductal carcinoma in situ (DCIS)or pleomorphic lobular carcinoma in situ (LCIS) (if present): positive: ink on tumour; close: <2mm; negative ≥2mm.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
3-Group Study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Combination Product: LightPath® Imaging System and 68Ga-RM2

    Imaging System:The LightPath® Imaging System is an in vitro diagnostic device which has CE mark in Europe, in line with In Vitro Diagnostic Medical Devices 98/79/EC (post-marketing study).

    Radiopharmaceutical: 68Ga-RM2 is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.

  • Drug: 68Ga-RM2
    Radiopharmaceutical: 68Ga-RM2 is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.
Study Arms  ICMJE
  • Group 1
    Patient will receive an IV injection of up to 200MBq 68Ga-RM2. Each patient will have torso PET/CT imaging at 2 timepoints. Alternate patients will have imaging at 1 and 2h post-injection then the next patientat 1 and 3h post-injection, with axillary gamma probe measurements (using a collimator) of 68Ga-RM2 at the same time points.
    Intervention: Drug: 68Ga-RM2
  • Experimental: Group 2
    WLE will be performed as per standard of care but will also include Intraoperative LightPath® Imaging with 68Ga-RM2. Group 2 scans will acquire LightPath® images of both intact and incised cancer specimens with varying parameters to optimise imaging.
    Intervention: Combination Product: LightPath® Imaging System and 68Ga-RM2
  • Experimental: Group 3
    WLE will be performed as per standard of care but will also include Intraoperative LightPath® Imaging with 68Ga-RM2. Group 3 scans will acquire LightPath® images of intact and incised cancer specimens using a final and consistent imaging procedure.
    Intervention: Combination Product: LightPath® Imaging System and 68Ga-RM2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have signed an informed consent form prior to any study related activity
  • Subjects who are able to give voluntary, written informed consent to participate in this study.
  • Subjects who are able to understand this study and are willing to complete all the study assessments
  • Female subjects ≥18 years of age with a diagnosis of ER-positive invasive breast cancer. ER-positivity is defined as an Allred score of 3 or more on immunohistochemical analysis.
  • Female subjects of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), or must have had a history of a surgical sterilisation, or must give history of no menses in the past twelve months
  • Groups 2 and 3: Subjects scheduled for WLE +/-SLNB or ALND

Exclusion Criteria:

  • Subjects who have had surgery in the operated breast in the past 12months
  • Subjects who have had radiotherapy in the operated breast
  • Subjects who have had neoadjuvant systemic therapy
  • Subjects who have had systemic chemotherapy or investigational therapy in the past two years
  • Subjects who are pregnant or lactating
  • Subjects who have a known hypersensitivity to 68Ga, bombesin analogues, or GRPR-antagonists
  • Subjects who have an existing medical condition that would compromise their participation in the study•Subjects with a current or active history of other known cancerin the opinion of the Investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qamar B Akbar, MSc +44 (0) 1494 917 697 qamar.akbar@lightpointmedical.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03731026
Other Study ID Numbers  ICMJE LPM-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lightpoint Medical Limited
Study Sponsor  ICMJE Lightpoint Medical Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Qamar B Akbar, MSc Lightpoint Medical Ltd
PRS Account Lightpoint Medical Limited
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP