PET CT With HX4 in Cervix Cancer (HX4-cervix)

Maastricht Radiation Oncology

Status and phase: Terminated; Phase 2

Conditions: Cervix Cancer

Treatments: Other: injection with [18F] HX4 and PET imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02233387

11-36-14/12

Details and patient eligibility

About

The aim of this study is:

1. to determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in cervix cancer,
2. to correlate the [18F]HX4 PET images with blood and tissue markers,
3. to investigate the quality and optimal timing of [18F]HX4 PET images,
4. to compare [18F]HX4 PET uptake with [18F]FDG PET uptake before and after treatment and
5. analyze correlation with responses

Full description

Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In Cervix cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. [18F]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, the investigators expect that [18F]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as [18F]-misonidazole. In a recent phase 1 clinical study from van Loon et al, PET-imaging with [18F]HX4 was feasible without any toxicity. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Histologically confirmed cervix carcinoma (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma)
• tumor stages FIGO IB - IVA
• WHO performance status 0 to 2
• Scheduled for primary curative 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

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

[18F] HX4 PET imaging

Experimental group

Description:

injection with \[18F\] HX4 and PET imaging at baseline and after 20 Gy radiotherapy

Treatment:

Other: injection with [18F] HX4 and PET imaging