Assessment of a novel hybrid radiopharmaceutical¿s use (ICG - 99mTc ¿ nanocolloid) applied in sentinel lymph node biopsy

Assessment of the feasibility and clinical efficacy of the ICG - 99mTc - nanocolloid for sentinel lymph node biopsy - Verde_Nano

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002978-13-IT

Enrollment

Registered

2021-06-08

Start date

2016-09-13

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with breast cancer or melanoma candidates for sentinel node biopsy surgery. The regional lymph nodes are the most common site of metastatic involvement in patients with cutaneous melanoma and breast cancer, before the disease spreads to other organs. The presence / absence of lymph node metastasis has been shown to be the most important way to predict survival and guide therapeutic choices in patients suffering from early- melanoma and breast cancer. MedDRA version: 20.1 Level: LLT Cla

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: VERDE INDOCIANINA Current Sponsor code: VERDE INDOCIANINA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Breast cancer Patients will be candidates of both sexes , aged = 18 , diagnosed with CT1 - T2N0M0 adenocarcinoma of the breast undergoing SLN biopsy; Informed consent must be signed by the patient . Melanoma Candidates will also be patients of both sexes , aged = 18 , suffering from cutaneous melanoma undergoing SLN biopsy, with Breslow thickness = 1 mm = 4 mm or Breslow = 1 mm , ulcerated and / or at least with 1 mitosis / mm2; Informed consent must be signed by the patient . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1 ) clinically positive lymph nodes 2 ) previous surgery of the breast 3 ) multicentric breast cancer , 4 ) the presence of local infection or inflammatory process in the site of administration of the radiopharmaceutical 5 ) pregnancy and lactation both excluded by anamnestic data collection 6 ) History of previous melanoma or other cancer except basal-cell carcinoma and in situ carcinoma of the uterine cervix 7 ) Inability of the patient to cooperate with the procedure 8 ) known hypersensitivity to products containing human albumin and / or indocyanine green with or excipients used in such drug formulations 9) Concomitant use of drugs that can reduce the absorption ICG : Anticonvulsants, bisulfites, haloperidol, heroin, meperidine, metamizole, methadone, nitrofurantoin, alcaliodi opium, phenobarbital, fenibutazione; Concomitant use of drugs that can increase the absorption ICG : cyclopropane , probenecid , rifamycin

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of this experimental study is to verify the clinical efficacy of the radiopharmaceutical 99mTc - ICG ¿ nanocolloid for Sentinel Lymph Node (SNL) biopsy in patients with breast cancer and melanoma, in terms of Identification Rate (IR, defined as the ratio between the number of surgical procedures in which at least one SLN is removed and the number of total surgical procedures performed ) ;Secondary Objective: 1) Calculation of the relationship between number of SLNs preoperatively displayed with lymphoscintigraphy and number of SLNs intraoperatively removed. 2) Calculation of the fluorescent / radioactive signal ratio for each SLN removed intraoperatively , as an index of the in vivo lymphnode uptake of the radiopharmaceutical . 3) data collection about hybrid radiopharmaceutical's safety assessment after its administered and during the follow-up ;Primary end point(s): Identification rate of the method ( defined as the ratio between the n ° of surgical procedures that removes at least one SLN on the number of total surgical procedures performed ) .;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed during surgical time	—

Measure

Time frame

Main Objective: The primary aim of this experimental study is to verify the clinical efficacy of the radiopharmaceutical 99mTc - ICG ¿ nanocolloid for Sentinel Lymph Node (SNL) biopsy in patients with breast cancer and melanoma, in terms of Identification Rate (IR, defined as the ratio between the number of surgical procedures in which at least one SLN is removed and the number of total surgical procedures performed ) ;Secondary Objective: 1) Calculation of the relationship between number of SLNs preoperatively displayed with lymphoscintigraphy and number of SLNs intraoperatively removed. 2) Calculation of the fluorescent / radioactive signal ratio for each SLN removed intraoperatively , as an index of the in vivo lymphnode uptake of the radiopharmaceutical . 3) data collection about hybrid radiopharmaceutical's safety assessment after its administered and during the follow-up ;Primary end point(s): Identification rate of the method ( defined as the ratio between the n ° of surgical procedures that removes at least one SLN on the number of total surgical procedures performed ) .;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed during surgical time

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Secondary

Measure	Time frame
Secondary end point(s): 1) Calculation of the relationship between n¿ of SLNs displayed by preoperative lymphoscintigraphy and n ¿ of SLNs intraoperatively removed . 2)Calculation of the fluorescent / radioactive signal ratio for each " sentinel node " removed intraoperatively and comparison with the reference value of the hybrid radiopharmaceutical . 3) Recording of any adverse events to the hybrid radiopharmaceutical at the time of administration (during lymphscintigraphy) or late (in the follow - up visit);Timepoint(s) of evaluation of this end point: The secondary endpoint 1 ) and 2 ) will be evaluated immediately after lymph nodes' surgical removal The endpoint Secondary 3 ) will be evaluated both during lymphoscintigraphy and in follow -up visit	—

Measure

Time frame

Secondary end point(s): 1) Calculation of the relationship between n¿ of SLNs displayed by preoperative lymphoscintigraphy and n ¿ of SLNs intraoperatively removed . 2)Calculation of the fluorescent / radioactive signal ratio for each " sentinel node " removed intraoperatively and comparison with the reference value of the hybrid radiopharmaceutical . 3) Recording of any adverse events to the hybrid radiopharmaceutical at the time of administration (during lymphscintigraphy) or late (in the follow - up visit);Timepoint(s) of evaluation of this end point: The secondary endpoint 1 ) and 2 ) will be evaluated immediately after lymph nodes' surgical removal The endpoint Secondary 3 ) will be evaluated both during lymphoscintigraphy and in follow -up visit

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Countries

Italy

Contacts

Public ContactU.O. medicina Nucleare

U.O. medicina Nucleare

g.manca@med.unipiit050993127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026