Status:
TERMINATED
Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma
Lead Sponsor:
John O. Prior
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 immun...
Detailed Description
According to the Swiss Federal Statistical Office, cancer has been the leading cause of death in Switzerland for men aged between 45 and 84 and women aged between 25 and 84. Melanoma, represents the d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04663126
Start Date
February 1 2021
End Date
June 19 2023
Last Update
December 13 2023
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011