EUCTR2016-004638-99-DK
Active, not recruiting
Phase 1
Phase II trial: uPAR PET/CT and FDG PET/CT for preoperative staging of gynecological cancers
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET0 sites350 target enrollmentJuly 4, 2017
Conditionsgynecological cancers:Vulvar cancerendometrial cancer (uterine cancer)cervical cancerovarian cancerMedDRA version: 20.0Level: LLTClassification code 10007107Term: Cancer of ovarySystem Organ Class: 100000021045MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000020935MedDRA version: 20.0Level: LLTClassification code 10047743Term: Vulval cancer NOSSystem Organ Class: 100000021101MedDRA version: 20.0Level: LLTClassification code 10007063Term: Cancer of endometriumSystem Organ Class: 100000021008MedDRA version: 20.0Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000020977Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- gynecological cancers:Vulvar cancerendometrial cancer (uterine cancer)cervical cancerovarian cancer
- Sponsor
- Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET
- Enrollment
- 350
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Biopsi verified cervical, vulvar or endometrial cancer.
- •\-Women refered for a suspected ovarian cancer with a RMI \> 200
- •\-The participants must be capable of understanding written and spoken Danish and \-may have given full informed written consent
- •\-age above 18
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 50
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 300
Exclusion Criteria
- •Lactation or breastfeading
- •Age above 85 years
- •Weight above 140 kg
- •Allergy Towards 68Ga\-NOTA\-AE105
- •Other active malignant disease within last 5 years
Outcomes
Primary Outcomes
Not specified
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