PET CT With HX4 in Cervix Cancer

NCT ID: NCT02233387

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-05-31

Brief Summary

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

Detailed 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.

Conditions

Cervix Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[18F] HX4 PET imaging

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

Group Type: EXPERIMENTAL

injection with [18F] HX4 and PET imaging

Intervention Type: OTHER

A standard clinical [18F]FDG PET-CT will be performed for the radiotherapy planning.

After a minimum time interval of 24 hours, baseline [18F]HX4 PET scans will be performed:

Based on the phase I trial1 444 MBq (12 mCi) [18F]HX4 is administrated via a bolus IV injection.

The first image acquisition is started together with the administration of [18F]HX4 (30-40 min dynamic). Static scans are acquired at 90 min, 180 min and 240 min p.i

Interventions

injection with [18F] HX4 and PET imaging

A standard clinical [18F]FDG PET-CT will be performed for the radiotherapy planning.

After a minimum time interval of 24 hours, baseline [18F]HX4 PET scans will be performed:

Based on the phase I trial1 444 MBq (12 mCi) [18F]HX4 is administrated via a bolus IV injection.

The first image acquisition is started together with the administration of [18F]HX4 (30-40 min dynamic). Static scans are acquired at 90 min, 180 min and 240 min p.i

Intervention Type: OTHER

Other Intervention Names

3-[18F]fluoro- 2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Lambin, prof MD PhD

Role: STUDY_DIRECTOR

Maastro Clinic, The Netherlands

Locations

MAASTRO clinic

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

11-36-14/12

Identifier Type: -

Identifier Source: org_study_id