Recurrent MelanomaNCT01898403

Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma

A study testing Indocyanine green solution, Isosulfan blue (ISB) and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) in people with Recurrent Melanoma, run by Stanford University at 1 site in United States.

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 clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Melanoma
What is being tested?: Indocyanine green solution, Isosulfan blue (ISB) and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Apr 2015
Phase: Interventional
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to understand and willingness to sign informed consent document
Signed written informed consent
Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
18 years of age or older
Complete blood count (CBC) and metabolic panel within 6 months

Who cannot join

History of hepatic or renal failure
Allergy to iodine containing products
Pregnant or may be pregnant
Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements
Undergoing dialysis

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University Hospitals and Clinics
Stanford, California, 94305

Other trials in United States

About this study

Official title: Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma

This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC).

Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.

Read the detailed description

PRIMARY OBJECTIVES:

To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).

OUTLINE:

Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).

Conditions: Recurrent Melanoma
Being tested: Indocyanine green solution, Isosulfan blue (ISB), Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Medical subject headings: Melanoma

What participants receive

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

Indocyanine green solutionDrug
Also called IC-GREEN (ICG), ICG solution
Administered peri-tumoral and intradermally
Isosulfan blue (ISB)Drug
Also called Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Administered peri-tumoral and intradermally
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)Diagnostic test
Also called TSC lymph node mapping

Study groups in NCT01898403
Study group	Role	What they receive
Sentinel Lymph Node (SLN) Detection	Experimental	All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective. Receives: Drug: Indocyanine green solution; Drug: Isosulfan blue (ISB); Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

What is being measured

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

Sentinel Lymph Nodes (SLN) Mapping
Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.
Measured: Up to 1 year

Timeline

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

Jun 2013Apr 2015

First posted12 Jul 2013 (estimated)
Study startJun 2013
Primary completionJun 2014
Study completionApr 2015

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 Recurrent MelanomaStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01898403
Sponsor's protocol ID: IRB-27319
Other IDs: NCI-2013-01286, MEL0010, P30CA124435
Status last verified: Jun 2015
First submitted: 3 Jul 2013
Last updated: 24 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Active, not recruitingPhase 2
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Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
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All Recurrent Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma
ClinicalTrials.gov ID: NCT01898403
Acronym / sponsor ID: IRB-27319
Conditions: Recurrent Melanoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jun 2013
Primary completion: Jun 2014 (actual)
Study completion: Apr 2015 (actual)
First posted: 12 Jul 2013 (estimated)
Results: Posted 24 May 2017

Clinical summary

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

This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC).

Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.

Detailed description

PRIMARY OBJECTIVES:

To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).

OUTLINE:

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sentinel Lymph Node (SLN) Detection	Experimental	Drug: Indocyanine green solution, Drug: Isosulfan blue (ISB), Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.

Who may qualify

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

Key inclusion criteria (5 listed)

Ability to understand and willingness to sign informed consent document
Signed written informed consent
Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
18 years of age or older
Complete blood count (CBC) and metabolic panel within 6 months

Key exclusion criteria (5 listed)

History of hepatic or renal failure
Allergy to iodine containing products
Pregnant or may be pregnant
Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements
Undergoing dialysis

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
Indocyanine green solutionAlso: IC-GREEN (ICG), ICG solutionAdministered peri-tumoral and intradermally	Drug	Sentinel Lymph Node (SLN) Detection
Isosulfan blue (ISB)Also: Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxideAdministered peri-tumoral and intradermally	Drug	Sentinel Lymph Node (SLN) Detection
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)Also: TSC lymph node mapping	Diagnostic test	Sentinel Lymph Node (SLN) Detection

Primary outcome

Sentinel Lymph Nodes (SLN) Mapping
Time frame: Up to 1 year
Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.

Results and safety

Results posted to the registry on 24 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sentinel Lymph Node (SLN) Detection	50	50

Primary outcome: Sentinel Lymph Nodes (SLN) Mapping

Time frame: Up to 1 year. Number. Unit: Sentinel lymph nodes

Measure	Sentinel Lymph Node (SLN) Detection by Isosulfan Blue n = 50	Sentinel Lymph Node (SLN) Detection by Indocyanine Green n = 50	Sentinel Lymph Node (SLN) Detection by TSC Lymphoscintigraphy n = 50
SLN detected by ISB, ICG, and TSC	25	25	25
SLN detected by ISB and TSC only	4	0	4
SLN detected by ICG and TSC only	0	9	9
SLN detected by ISB and ICG only	10	10	0
SLN detected by ISB plus any/none	41	0	0
SLN detected by ISB only	2	0	0
SLN detected by ICG plus any/none	0	47	0
SLN detected by ICG only	0	3	0

Population analysed: All participants were evaluated for sentinel lymph nodes (SLN) using Isosulfan Blue (ISB); Indocyanine Green (ICG); and TSC lymphoscintigraphy.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sentinel Lymph Node (SLN) Detection	0 of 50 (0%)	5 of 50 (10%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Recurrent Melanoma

Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer

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.

Ralph Greco principal investigator

Stanford University Hospitals and Clinics

1 site in 1 country: 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 5 inclusion and 5 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 24 May 2017. 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?

Yes. Results are posted in the registry (first posted 24 May 2017). 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?

Sentinel Lymph Nodes (SLN) Mapping (time frame: Up to 1 year). 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 NCT01898403.

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 24 May 2017.