E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cervical cancer |
cervix cancer |
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E.1.1.1 | Medical condition in easily understood language |
cervical cancer |
livmoderhalskræft |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
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 | 10008229 |
E.1.2 | Term | Cervical cancer |
E.1.2 | System Organ Class | 100000004864 |
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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 | 10008233 |
E.1.2 | Term | Cervical cancer stage I |
E.1.2 | System Organ Class | 100000004864 |
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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 | 10008234 |
E.1.2 | Term | Cervical cancer stage II |
E.1.2 | System Organ Class | 100000004864 |
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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 | 10008235 |
E.1.2 | Term | Cervical cancer stage III |
E.1.2 | System Organ Class | 100000004864 |
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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 | 10008236 |
E.1.2 | Term | Cervical cancer stage IV |
E.1.2 | System Organ Class | 100000004864 |
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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 |
We study patients with cervical cancer stage IB2-IV during radiotherapy treatment. This is carried out by adding angiogenesis PET scan to the usual MR scan. |
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E.2.2 | Secondary objectives of the trial |
the prognostic value of angiogenesis PET for predicting progressionfree survival and overall survival. An angiogeneses PET will be performed as a baseline scan before and after external radiation therapy.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria
• Diagnosed with cervical cancer stage IB2-IVA
• Tumor > 1cm
• Referred for EBRT and BT planning
• Age > 18 years
• Informed consent
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E.4 | Principal exclusion criteria |
Exclusion criteria
• Prior RT of the pelvic region
• Pregnancy and lactation
• Claustrophobia
• MR-incompatible implants
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E.5 End points |
E.5.1 | Primary end point(s) |
angiogenesis PET/MR with the 68Ga-NODAGA- E[c(RGDyK)]2 can be used to visualize cervical tumors, and change as a response to the treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
uptake of the radioligand in tumor lesions from angiogenesis PET performed 45 min post injektion of 68Ga-NODAGA- E[c(RGDyK)]2 . |
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E.5.2 | Secondary end point(s) |
- prognostic information (correlation of 68Ga-NODAGA- E[c(RGDyK)]2 uptake in tumor lesions)
- progression free survival
- disease free survival
- overall survival |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- progression free survival (12 month)
- disease free survival (12 month)
- overall survival (12 month) |
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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 | No |
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
|
Patient recruitment september 2018/when approval until september 2021. and then 1 year followup. |
sidste besøg af sidste patient og 1 års follow up. Førsøget inkluderer patienter fra september 2018/når godkendelse foreligger - og til september 2021. Herefter 1 år Followup. |
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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 | |