## Protocol Section
### Identification Module
**NCT ID:** NCT04261179

**Acronym:** SENTINELSEEK

**Brief Title:** Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer

**Official Title:** An Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.

#### Organization Study ID Info
**ID:** 2019-003825-56
#### Organization
**Class:** OTHER
**Full Name:** Fundacion Clinic per a la Recerca Biomédica
### Status Module
#### Completion Date
**Date:** 2021-08

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2020-02-20

**Type:** ACTUAL

**Last Update Submit Date:** 2020-02-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-03

**Type:** ESTIMATED

**Status Verified Date:** 2020-02

#### Study First Post Date
**Date:** 2020-02-07
**Type:** ACTUAL
**Study First Submit Date:** 2020-02-05
**Study First Submit QC Date:** 2020-02-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Anna Cruceta

#### Responsible Party

**Investigator Affiliation:** Fundacion Clinic per a la Recerca Biomédica

**Investigator Full Name:** Anna Cruceta

**Investigator Title:** Project Manager

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams

### Conditions Module

**Conditions:**

- Head Cancer

- Neck Cancer

- Melanoma

- Breast Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams

**Intervention Names:**

- Drug: Lymphoseek

- Drug: Nanocoll

**Label:** Lymphoseek + Nanocoll

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lymphoseek + Nanocoll

**Description:** 50 μg microgram(s), timepoint: 30-60 minutes

**Name:** Lymphoseek

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Lymphoseek + Nanocoll

**Description:** 500 μg microgram(s), timepoint: 30-60 minutes

**Name:** Nanocoll

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal

**Measure:** Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies

**Time Frame:** for at least 48 consecutive hours

#### Secondary Outcomes

**Measure:** Time frame to ascertain the sentinel nodes

**Time Frame:** 1 week

**Measure:** Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.

**Time Frame:** 1 week

**Measure:** Number of sentinel nodes and secondary nodes depicted

**Time Frame:** 1 week

**Measure:** Tracer retention in injection site

**Time Frame:** 1 week

**Description:** Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid

**Measure:** Safety and tolerability of 99mTctilmanocept (Lymphoseek®)

**Time Frame:** 1 week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Written informed consent
* Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
* At least 18 years of age at the time of consent.
* The subject is clinically node negative (cN0) at the time of screening.
* In Melanoma Patients

  * Diagnosis of primary melanoma with sentinel node indication ( \>0.8 mm Breslow thickness; clinically negative lymph nodes)
* In Breast Cancer Patients

  * T1-T2 N0 breast cancer.
  * Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan.
* In Oral cavity tumors patients

  * T1-T2 N0 oral cavity squamous cell carcinoma

Exclusion Criteria:

* Pregnancy or lactation
* Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
* Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
* Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
* Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Email:** acruceta@clinic.ub.es

- **Name:** Anna Cruceta Arboles, MD

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Clínico y provincial de Barcelona

**Zip:** 08036

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000018358

- Term: Neuroendocrine Tumors

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

- ID: D000018326

- Term: Nevi and Melanomas

- ID: D000012878

- Term: Skin Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M11528

- Name: Melanoma

- Relevance: HIGH

- As Found: Melanoma

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: HIGH

- As Found: Head Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20495

- Name: Neuroendocrine Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12448

- Name: Nevus, Pigmented

- Relevance: LOW

- As Found: Unknown

- ID: M12446

- Name: Nevus

- Relevance: LOW

- As Found: Unknown

- ID: M20470

- Name: Nevi and Melanomas

- Relevance: LOW

- As Found: Unknown

- ID: M15681

- Name: Skin Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000008545

- Term: Melanoma

- ID: D000006258

- Term: Head and Neck Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
