E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
gynecological cancers: Vulvar cancer endometrial cancer (uterine cancer) cervical cancer ovarian cancer |
kræft i æggestokken kræft i livmoderen kræft i livmoderhalsen kræft i ydre kønsorganer (vulva) |
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E.1.1.1 | Medical condition in easily understood language |
gynecological cancers: Vulvar cancer endometrial cancer (uterine cancer) cervical cancer ovarian cancer |
kræft i æggestokken kræft i livmoderen kræft i livmoderhalsen kræft i ydre kønsorganer (vulva) |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007107 |
E.1.2 | Term | Cancer of ovary |
E.1.2 | System Organ Class | 100000021045 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007050 |
E.1.2 | Term | Cancer |
E.1.2 | System Organ Class | 100000020935 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047743 |
E.1.2 | Term | Vulval cancer NOS |
E.1.2 | System Organ Class | 100000021101 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007063 |
E.1.2 | Term | Cancer of endometrium |
E.1.2 | System Organ Class | 100000021008 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008229 |
E.1.2 | Term | Cervical cancer |
E.1.2 | System Organ Class | 100000020977 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
Livmoderhalskræft: Biopsiverificeret planocellulært carcinom udgående fra livmoderhalsen Alle patienter diagnosticeret klinisk som stadie >=1B1 og < 4
Kræft i æggestokken: Alle patienter henvist under diagnosen kræft i æggestokken obs pro og med et RMI >= 200
Kræft i livmoderen: Præoperativt formodet stadie >1A (grad 3 samt serøse og clear cell subtyper) samt mistanke om stadie 2 og 3
Kræft i vulva Biopsiverificeret planocellulært karcinom udgået fra vulva Alle stadier > 1B1 og < IV
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Detection of lymph node metastasis in pelvine and paraaortal regions by 68GA-NOTA-AE105 PET/CT |
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E.5.1.1 | 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 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
diagnostic performance (sensitivity/specificity, NPV and PPV) of uPAR PET/CT |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |