Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma

NCT04663126 | Terminated Early Phase 1

• 1 other identifier: Tilmanocept
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study in 20 patients is designed as a monocentric, open-label and uncontrolled, exploratory pilot study. Patients diagnosed with advanced melanoma (stage III-IV) and scheduled for anti-PD-1 immunotherapy will be recruited for this project. Patients will receive IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m (bolus injection) according to the Navidea's protocol in our GMP certified radiopharmaceutical unit, before the first cycle of clinically scheduled immunotherapy. Scintigraphy images will be acquired dynamically from time of injection to +30 minutes. Quantitative SPECT/CT (xSPECT/CT, Siemens Symbia Intevo, Erlangen, Germany) imaging will be performed up to 1 hour p.i. to evaluate hyperaemia, and up to 3 hours p.i. to image and measure the CD206 receptor uptake. The data of the scans will be compared to immunohistochemistry results from biopsy staining for TAMs and M2-like TAMs and retrospectively with response to the immunotherapy to determine any correlation between M2-like TAMs and treatment response. For the planned retrospective comparison we will use the FDG - PET/CT data that is done after the immunotherapy as standard of care. We will analyse the lesion size and FDG - uptake in standard of care PET/CT of CD206+ and CD206 negative lesions in Tilmanocept SPECT/CT before and after immunotherapy to determine any correlation between CD206 related uptake and treatment response.

Conditions

Melanoma

Keywords

Macrophages M2

Outcome Measures

Primary Outcomes (1)

• Imaging results

  The primary endpoint is the imaging result obtained by scintigraphy/SPECT at day 0 as lesion number and site, compared to standard of care clinical imaging (FDG - PET/CT) per lesion and per patient.

  3 hours post injection

Secondary Outcomes (2)

• Immunohistochemistry

  1 week after scan

• Retrospective analysis

  1 week after scan

Study Arms (1)

Treatment group

EXPERIMENTAL

Patients diagnosed with advanced melanoma (stage III-IV) will receive IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m before the first cycle of clinically scheduled anti-PD-1 immunotherapy.

Drug: Tc-99m tilmanocept

Interventions

Tc-99m tilmanocept DRUG

IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m

Also known as: Lymphoseek

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male
• Age ≥ 18
• Diagnosis of having advanced melanoma , stage III-IV
• Scheduled for clinically indicated anti-PD-1 immunotherapy
• Informed Consent as documented by signature
• FDG PET/CT within 4 weeks before screening
• Biopsy available
• Minimum 3 lesions detected in FDG PET/CT

You may not qualify if:

• Age under 18
• Ocular melanoma
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons,
• Previous immunotherapy,
• History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
• The subject has a known allergy to or has had an adverse reaction to dextran exposure
• Insufficient knowledge of project language, inability to give consent or to follow procedures
• The patient makes use of his/her "right not to know" and refuses to be informed about incidental findings

Sponsors & Collaborators

• John O. Prior: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

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MeSH Terms

Conditions

Melanoma

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Niklaus Schaefer, Prof.

  CHUV Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department, Service of Nuclear Medicine and Molecular Imaging

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 10, 2020
• Study Start: February 1, 2021
• Primary Completion: January 8, 2023
• Study Completion: June 19, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)