Penile CancerNANOSCANNCT06666634
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
A study testing Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan in people with Penile Cancer and Melanoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Penile Cancer, Melanoma, Oral Cancer
- What is being tested?
- Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2023to 14 Jul 2025
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who will undergo a sentinel node procedure in routine care.
- Patients > 18 years;
- Patients presenting with:
- a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities;
- OR patients presenting with a primary oral cavity malignancy T1-2N0
- OR patients with primary penile cancer
Show all 9Show fewer
- Patients with clinical N0 stage;
- Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion;
- Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting
Who cannot join
- Patients with known allergy to patent blue dye or nanocolloid;
- Patients who are pregnant or breast-feeding mothers;
- History of hypersensitivity reactions to products containing human serum albumin;
- History of iodine allergy
- Hyperthyroid or thyroidal adenoma
- Kidney insufficiency
- Incapacity or unwillingness of participant to give written informed consent;
Trial locations and contacts
1 site in 1 country.
About this study
99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.
Read the detailed description
The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.
- Conditions
- Penile Cancer, Melanoma, Oral Cancer
- Being tested
- Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
- Keywords
- Fluorescence, Radioactivity, Indocyanine green, Clinical node negative patients, Surgical staging
- Medical subject headings
- Penile Neoplasms, Melanoma, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscanDrug
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
| Study group | Role | What they receive |
|---|---|---|
| Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan | Other | The patient first receives a one-time injection with 99mTc-nanoscan, then a one-time injection with ICG-99mTc-nanoscan, both dosage are according to routine care. Receives: Drug: Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between tracers
To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
Measured: Measured at pre-operative imaging
Secondary outcomes (3)
Higher echelon nodes
Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan);
Measured: Measured at pre-operative imaging
Concordance between intraoperative fluorescence and radioactive findings
Number of the fluorescent nodes at time of excision;
- Number and radioactive signal intensity of the radioactive nodes at time of excision;
Measured: Measured at pre-operative imaging
Concordance between intraoperative fluorescence and radioactive findings
intensity of the fluorescent nodes at time of excision;
Measured: Measured at pre-operative imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Apr 2023
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666634
- Sponsor's protocol ID
- N21NAN
- Acronym
- NANOSCAN
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
- ClinicalTrials.gov ID
- NCT06666634
- Acronym / sponsor ID
- NANOSCAN / N21NAN
- Conditions
- Penile Cancer, Melanoma, Oral Cancer
- Keywords
- Fluorescence, Radioactivity, Indocyanine green, Clinical node negative patients, Surgical staging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- 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.
99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.
Detailed description
The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan | Other | Drug: Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscanThe patient first receives a one-time injection with 99mTc-nanoscan, then a one-time injection with ICG-99mTc-nanoscan, both dosage are according to routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient who will undergo a sentinel node procedure in routine care.
- Patients > 18 years;
- Patients presenting with:
- a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities;
- OR patients presenting with a primary oral cavity malignancy T1-2N0
Key exclusion criteria (7 listed)
- Patients with known allergy to patent blue dye or nanocolloid;
- Patients who are pregnant or breast-feeding mothers;
- History of hypersensitivity reactions to products containing human serum albumin;
- History of iodine allergy
- Hyperthyroid or thyroidal adenoma
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 |
|---|---|---|
| Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscanSentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan | Drug | Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan |
Primary outcome
Concordance between tracers
Time frame: Measured at pre-operative imaging
To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
3 secondary outcomes
Higher echelon nodes
Time frame: Measured at pre-operative imaging
Concordance between intraoperative fluorescence and radioactive findings
Time frame: Measured at pre-operative imaging
Concordance between intraoperative fluorescence and radioactive findings
Time frame: Measured at pre-operative imaging
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 22 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan in people with Penile Cancer and Melanoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 9 inclusion and 7 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 22 Jul 2026. 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 Netherlands. 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?
Concordance between tracers (time frame: Measured at pre-operative imaging). 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 22 Jul 2026.