Breast CancerPhase 3FILM-BNCT03200704

A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

A Phase 3 study testing IC2000 and SPY-PHI and Tc-99m radioactive colloid and Gamma Probe in people with Breast Cancer and Lymph Node Mapping, run by Novadaq Technologies ULC, now a part of Stryker at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy
What is being tested?: IC2000 and SPY-PHI and Tc-99m radioactive colloid and Gamma Probe
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 7 sitesin 2 countries
Study dates: 4 Jan 2019to 28 Sep 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Be 18 years of age or older
Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1*, N0, M0), IB ((T0, N1mi, M0) or T1*, N1mi, M0)) or Stage IIA (T0, N1M0, or T1, N1, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.
Where:
Tis = Ductal carcinoma in situ
T0 = No evidence of primary tumor
T1 = Tumor ≤ 20 mm in greatest diameter

Show all 20Show fewer

T1* = Includes T1mi
T2 = Tumor >20 mm but ≤ 50 mm in greatest diameter
N0 = No regional lymph node metastasisq1'
N1 = Metastasis to movable ipsilateral level I, II axillary LNs
N1** = T0 and T1 tumors with nodal micro-metastasis only are excluded from Stage IIA and are classified Stage IB.
mi = Micro-metastasis
M0 = Disease has not metastasized from Stage IIA and are classified Stage IB.
M0= No evidence of metastasis
mi= Micrometastasis
Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy
Subjects with negative metastatic involvement (M0)
Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline
Have signed an approved informed consent form for the study
Be willing to comply with the protocol

Who cannot join

Have had prior axillary surgery or ipsilateral radiation in the breast(s) that is planned for the procedure
Advanced breast cancer subjects with stage IIB, III and IV
Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
Subjects who have participated in another investigational study within 30 days prior to surgery
Pregnant or lactating subject
Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States5 sites

Inova Health System
Alexandria, Virginia, 22306
Methodist Dallas Medical Center
Dallas, Texas, 75203
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Arizona Center for Cancer Care
Scottsdale, Arizona, 85258
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

Canada2 sites

Fraser Health Authority
Port Moody, British Columbia, V3H 3W9
CHU de Québec-Université Laval (Hôpital du Saint-Sacrement)
Québec, Quebec, G1R 2J6

Other trials in Canada

About this study

Official title: Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

Conditions: Breast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy
Being tested: IC2000 and SPY-PHI, Tc-99m radioactive colloid and Gamma Probe
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IC2000 and SPY-PHICombination product
Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma ProbeCombination product
Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer

Study groups in NCT03200704
Study group	Role	What they receive
IC2000/SPY-PHI	Experimental	Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised. Receives: Combination Product: IC2000 and SPY-PHI; Combination Product: Tc-99m radioactive colloid and Gamma Probe

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
Measured: From Technetium-99 (Tc-99m) injection to the completion of surgery

Secondary outcomes (3)

Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe
Measured: From Technetium-99 (Tc-99m) injection to the completion of surgery
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI
Measured: From Technetium-99 (Tc-99m) injection to the completion of surgery
To Assess the Safety of Intradermal Injection of IC2000
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From Technetium-99 (Tc-99m) injection to the completion of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 201928 Sep 2020

First posted27 Jun 2017
Study start4 Jan 2019
Primary completion27 Aug 2020
Study completion28 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single arm, open label, within patient study
Masking: None (open label)
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03200704
Sponsor's protocol ID: SPY LNM 01
Acronym: FILM-B
Status last verified: Aug 2023
First submitted: 22 Jun 2017
Last updated: 21 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
ClinicalTrials.gov ID: NCT03200704
Acronym / sponsor ID: FILM-B / SPY LNM 01
Conditions: Breast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Novadaq Technologies ULC, now a part of StrykerIndustry (pharma, biotech, devices)
Study start: 4 Jan 2019 (actual)
Primary completion: 27 Aug 2020 (actual)
Study completion: 28 Sep 2020 (actual)
First posted: 27 Jun 2017 (actual)
Results: Posted 21 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single arm, open label, within patient study

Arm	Type	Receives
IC2000/SPY-PHI	Experimental	Combination Product: IC2000 and SPY-PHI, Combination Product: Tc-99m radioactive colloid and Gamma ProbePer standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Be 18 years of age or older
Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1*, N0, M0), IB ((T0, N1mi, M0) or T1*, N1mi, M0)) or Stage IIA (T0, N1M0, or T1, N1, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.
Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy
Subjects with negative metastatic involvement (M0)
Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline

Key exclusion criteria (6 listed)

Have had prior axillary surgery or ipsilateral radiation in the breast(s) that is planned for the procedure
Advanced breast cancer subjects with stage IIB, III and IV
Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
Subjects who have participated in another investigational study within 30 days prior to surgery
Pregnant or lactating subject

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
IC2000 and SPY-PHIInvestigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer	Combination product	IC2000/SPY-PHI
Tc-99m radioactive colloid and Gamma ProbeComparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer	Combination product	IC2000/SPY-PHI

Primary outcome

Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery

3 secondary outcomes

Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery
To Assess the Safety of Intradermal Injection of IC2000
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery

Results and safety

Results posted to the registry on 21 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IC2000/SPY-PHI	152	151

Primary outcome: Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe

Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery. Count of units. Unit: Lymph Nodes

Measure	IC2000/SPY-PHI n = 148
Proportion of histology confirmed lymph nodes identified using IC2000 and SPY	360
Proportion of histology confirmed lymph nodes identified using Tc-99m/Gamma Probe	266

IC2000/SPY-PHI: p <0.0001, Regression, Logistic

Population analysed: PP and mITT populations

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collected over the treatment duration period (Day 0) and followed through to Day 30. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IC2000/SPY-PHI	4 of 151 (2.6%)	27 of 151 (17.9%)	0 of 151

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

Active, not recruiting
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RecruitingPhase 2
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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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RecruitingPhase 3
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

David Weintritt, MD, FACS principal investigator

National Breast Center

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe (time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery). 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 NCT03200704.

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 21 Sep 2023.