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

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

Status
Unknown
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37407
Enrollment
20
Registered
2012-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

cervix cancer

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Histological or cytological confirmed Cervix squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of Uterine Cervix; -tumor stages FIGO Ib - IVa; -WHO performance status 0 to 2; -Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia); - willing to take adequate contraceptive measures during the study - The patient is willing and capable to comply with study procedures; - 18 years or older; -Have given written informed consent before patient registration; - no previous surgery to the Cervix; - no previous radiation to the Cervix;

Exclusion criteria

Exclusion criteria: recent

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Tumor to background ratio of [18F] HX4 PET images.

Secondary

MeasureTime frame
Secondary endpoints: - Overlap fraction of (for example) >50% max regions (i) before and during treatment (ii) in the time series. - Define the optimal time point for HX4 imaging in Cervix cancer, based on the highest tumor to background ratio. - Determine if there is a relationship between the SUVmax, SUVmean or tumor to muscle ratio in comparison to the amount of osteopontin in the blood, circulating CA-IX in the blood or the degree and presence of tumor tissue markers. - Overlap fraction of (for example) >50% max regions between HX4-PET and FDG-PET pre-treatment or three months after treatment. - Correlation of the SUVmax, SUVmean and tumor to muscle ratio in the [18F] HX4 PET images in comparison to local tumor recurrence and survival. - Correlation of the SUVmax, SUVmean and tumor to muscle ratio in the [18F] HX4 PET images in comparison to Complete Remission rates at 3 months

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)