Imaging of tumor hypoxia with [18F]HX4 PET

Phase 1

• Conditions: Eligible patients with histologically/cytologically proven primary tumors of the prostate, esophagus, brain or rectum or metastatic disease to the brain (originating from breast, lung or colorectal).; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003873-41-NL
• Lead Sponsor: MAASTRO Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-09
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

General:
-Primary tumor site: prostate, esophagus, grade IV glioma or rectum
- Metastastic disease to brain (originating from e.g., breast, lung or colorectal primary tumor)
-WHO performance status 0 to 2
- No chronic renal function failure or no renal dialysis
- The patient is willing and capable to comply with study procedures
- 18 years or older
- Have given written informed consent before patient registration

Prostate
-Histological confirmed prostate tumor
-High grade tumor (Gleason score =8)
-Macroscopically visual tumor on MRI
-Tumorload based on biopsy > 25%
-Eligible for HDR-brachytherapy followed by external beam radiotherapy
-No previous surgery of the prostate.
-No previous radiotherapy of the prostate
-No previous chemotherapy or hormonal therapy

Esophagus
-Histological or cytological confirmed esophageal tumor
-Tumor length = 2,5 cm
-No previous surgery to the esophagus
-No previous radiotherapy of the esophagus.
-No previous chemotherapy.

Brain (primary)
-Preferably histologically proven, or highly suspicious for malignancy
-Primary grade IV glioma (glioblastoma)
-Macroscopically visual tumor on MRI ( , diameter larger than 0.5cm)
-No complete tumor removal at surgery, only biopsy or partial debulking
-no previous chemotherapy

Brain (metastases)
-brain metastases (originating from the lung, breast or colorectal)
-macroscopically visual tumor on MRI (diameter larger than 1.5 cm and suitable for SBRT)
-planned for curative treatment with stereotactic body radiotherapy (SBRT)
-No chemotherapy 4 weeks before planned scan-date.

Rectum
-Histologically confirmed rectum tumor
-tumor size diameter = 2,5 cm
-eligible for long-course radiochemotherapy
-No previous surgery or radiotherapy of the rectum
-No previous chemotherapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Recent (< 3 months) myocardial infarction
- Pregnant or breast feeding and willing to take adequate contraceptive measures during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified