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Clinical Trials/EUCTR2016-002082-65-DK
EUCTR2016-002082-65-DK
Active, not recruiting
Phase 1

Phase II trial: uPAR-PET/CT for prognostication in head- and neck cancer

Andreas Kjaer0 sitesSeptember 19, 2016
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ConditionsHead and neck cancerMedDRA version: 19.0Level: HLTClassification code 10026660Term: Malignant oral cavity neoplasmsSystem Organ Class: 100000004856MedDRA version: 19.0Level: HLTClassification code 10028801Term: Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecifiedSystem Organ Class: 100000004864MedDRA version: 19.0Level: HLTClassification code 10023826Term: Laryngeal neoplasms malignantSystem Organ Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Head and neck cancer
Sponsor
Andreas Kjaer
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Andreas Kjaer

Eligibility Criteria

Inclusion Criteria

  • •The patient has a diagnosis of biopsy\-verified cancer of the pharynx, larynx or oral cavity, is
  • •referred to curative intended radiotherapy, understands the given information and has given informed consent
  • •and Age \> 18 years
  • •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 104
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Lactation/breast feeding
  • •Age \> 85 Years
  • •Obesity (bodyweight \>140 kg)
  • •Small cancers of the larynx (1A/1B)
  • •Allergy to 68Ga\-NOTA\-AE105
  • •Metastasis on the FDG\-PET/CT
  • •Other previously known cancers
  • •Claustrophobia

Outcomes

Primary Outcomes

Not specified

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