Imaging of tumor hypoxia with [18F]HX4 PET

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2014-003873-41-NL
• Date of registration: 09/07/2015
• Prospective Registration: Yes
• Primary sponsor: MAASTRO Clinic
• Public title: Imaging of tumor hypoxia with [18F]HX4 PET
• Scientific title: Non invasive imaging of tumor hypoxia with [18F]HX4 Positron-Emission-Tomography (PET): A phase II trial - HX4 several disease
• Date of first enrolment: 09/07/2015
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003873-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: MAASTRO Clinic
• Affiliation: MAASTRO Clinic

• Name: MAASTRO Clinic
• Affiliation: MAASTRO Clinic

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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]

Intervention(s)

Product Name: [18F]HX4
Product Code: [18F]HX4
Pharmaceutical Form: Radiopharmaceutical precursor, solution
INN or Proposed INN: [18F]HX4
Other descriptive name: [18F]HX4
Concentration unit: MBq megabecquerel(s)
Concentration type: up to
Concentration number: 444-

Primary Outcome(s)

Main Objective: Tumor to background ratio of [18F] HX4 PET images.

Primary end point(s): Tumor to background ratio of [18F] HX4 PET images.

Secondary Objective: - Correlation of the SUVmax, SUVmean, SUVpeak and tumor to background ratio in the [18F] HX4 PET images in comparison to local tumor recurrence and survival.
- Determine if there is a relationship between the SUVmax, SUVmean, SUVpeak or tumor to background ratio in comparison to blood or tissue biomarkers.
- Overlap fraction of (for example) >50% max regions between HX4-PET and FDG-PET pre-treatment or three months after treatment.
- Quantitative and qualitative correlation of [18F] HX4-PET obtained before treatment and two weeks into treatment

Timepoint(s) of evaluation of this end point: This endpoint will be evaluated approximately 3 months after inclusion of all patients.

Secondary Outcome(s)

Secondary end point(s): - Correlation of the SUVmax, SUVmean, SUVpeak and tumor to background ratio in the [18F] HX4 PET images in comparison to local tumor recurrence and survival.
- Determine if there is a relationship between the SUVmax, SUVmean, SUVpeak or tumor to background ratio in comparison to blood or tissue biomarkers.
- Overlap fraction of (for example) >50% max regions between HX4-PET and FDG-PET pre-treatment or three months after treatment.
- Quantitative and qualitative correlation of [18F] HX4-PET obtained before treatment and two weeks into treatment

Timepoint(s) of evaluation of this end point: These secondary endpoints will be evaluated 2 years after the inclusion of all patients, since we want correlate hypoxia PET imaging to (at least) 2-year overall survival.

Secondary ID(s)

14-23-16/07

Source(s) of Monetary Support

MAASTRO Clinic

Ethics review

Status: Approved
Approval date: 17/06/2015
Contact: