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PSMA-PET scan for incurable or metastatic salivary gland cancer

Phase 1
Conditions
Patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma or salivary duct carcinoma
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2017-002093-40-NL
Lead Sponsor
Radboudumc
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
25
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•locally advanced, recurrent or metastatic ACC/SDC
•Age = 18 years old
•Ability to provide written informed consent

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 10

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Contra-indication for PET imaging (pregnancy, breast feeding, severe claustrophobia)
•Impaired renal function: MDRD <30 ml/min/1,73 m2
•Impaired liver function: AST and ALT = 2.5 x ULN (=5 x ULN for patients with liver metastases)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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