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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04261179
Other study ID # 2019-003825-56
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date March 2020
Est. completion date August 2021

Study information

Verified date February 2020
Source Fundacion Clinic per a la Recerca Biomédica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Drug:
Lymphoseek
50 µg microgram(s), timepoint: 30-60 minutes
Nanocoll
500 µg microgram(s), timepoint: 30-60 minutes

Locations

Country Name City State
Spain Hospital Clínico y provincial de Barcelona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Anna Cruceta

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal for at least 48 consecutive hours
Secondary Time frame to ascertain the sentinel nodes 1 week
Secondary Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images. 1 week
Secondary Number of sentinel nodes and secondary nodes depicted 1 week
Secondary Tracer retention in injection site 1 week
Secondary Safety and tolerability of 99mTctilmanocept (Lymphoseek®) Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid 1 week
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