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Clinical Trials/EUCTR2017-002093-40-NL
EUCTR2017-002093-40-NL
Active, not recruiting
Phase 1

68Ga-PSMA-PET/CT imaging for locally advanced, recurrent and metastatic adenoid cystic carcinoma or salivary duct carcinoma - PSMA-PET imaging for advanced ACC/SDC

Radboudumc0 sites25 target enrollmentJune 8, 2017

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Radboudumc
Enrollment
25
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 8, 2017
End Date
May 14, 2018
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Radboudumc

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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