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

Phase II trial: uPAR PET/CT and FDG PET/CT for preoperative staging of gynecological cancers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004638-99-DK

Enrollment

350

Registered

2017-07-04

Start date

2017-11-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gynecological cancers: Vulvar cancer endometrial cancer (uterine cancer) cervical cancer ovarian cancer MedDRA version: 20.0 Level: LLT Classification code 10007107 Term: Cancer of ovary System Organ Class: 100000021045 MedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000020935 MedDRA version: 20.0 Level: LLT Classification code 10047743 Term: Vulval cancer NOS System Organ Class: 100000021101 MedDRA version: 20.0 Level: LLT Classification c

Interventions

Product Name: 68Ga-NOTA-AE105 Product Code: 68Ga-NOTA-AE105 Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: 68Ga-NOTA-AE105 CAS Number: NA Current

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

Denmark

Contacts

Public ContactTine Henrichsen Schnack

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET

tine.henrichsen.schnack@regionh.dk004535453838

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026