uPAR PET/CT og FDG PET/CT til præoperativ stadieinddeling af patienter med nydiagnosticeret Gynækologisk Kræft

Phase 1

• Conditions: gynecological cancers:Vulvar cancerendometrial cancer (uterine cancer)cervical cancerovarian cancer; MedDRA version: 20.0Level: LLTClassification code 10007107Term: Cancer of ovarySystem Organ Class: 100000021045; MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000020935; MedDRA version: 20.0Level: LLTClassification code 10047743Term: Vulval cancer NOSSystem Organ Class: 100000021101; MedDRA version: 20.0Level: LLTClassification code 10007063Term: Cancer of endometriumSystem Organ Class: 100000021008; MedDRA version: 20.0Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000020977; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2016-004638-99-DK
• Lead Sponsor: Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-04
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 350

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

Pregnancy
Lactation or breastfeading
Age above 85 years
Weight above 140 kg
Allergy Towards 68Ga-NOTA-AE105
Other active malignant disease within last 5 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT for detection of lymph nodes metastasis will be tested by observer-blinded readings and compared to standard diagnostic performance of conventional preoperative procedure (FDG PET/CT). The reference test will be histopathology of lymph nodes obtained by standard operative lymph node dissection. During the operation the lymph nodes will be removed and analysed from specifically prespecified regions.;Secondary Objective: no secondary objectives ;Primary end point(s): Detection of lymph node metastasis in pelvine and paraaortal regions by 68GA-NOTA-AE105 PET/CT;Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoints from the PET scan performed within 1 hour post injection of 68GA-NOTA-AE105

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none