on invasive imaging of [18F]HX4 with Positron-Emission-Tomography (PET) in Cervix Cancer.

Phase 2

Completed

• Conditions: 10038594; cervix cancer

• Registration Number: NL-OMON44375
• Lead Sponsor: MAASTRO clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 38

Inclusion Criteria

-Histologically confirmed cervix carcinoma (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma)
-WHO performance status 0 to 2
-Scheduled for primary curative surgery or radiotherapy (either or not combined with chemotherapy or hyperthermia)
- No previous surgery to the cervix
- No previous radiation to the cervix
- The patient is willing and capable to comply with study procedures
- 18 years or older
-Written informed consent before patient registration;Group A:
-FIGO stage IB, minimal tumour diameter 2cm.;Group B:
- FIGO stage IB (minimal tumour diameter 2 cm) - IVA

Exclusion Criteria

-recent (< 3 months) myocardial infarction
-uncontrolled infectious disease
-pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Tumor to background ratio of [18F] HX4 PET images.</p><br>