Cervix CancerPhase 2HX4-cervixNCT02233387
PET CT With HX4 in Cervix Cancer
A Phase 2 study testing injection with [18F] HX4 and PET imaging in people with Cervix Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- injection with [18F] HX4 and PET imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- The patient is willing and capable to comply with study procedures
- 18 years or older
- Written informed consent before patient registration
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Cervix Cancer.
The aim of this study is:
- to determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in cervix cancer,
- to correlate the [18F]HX4 PET images with blood and tissue markers,
- to investigate the quality and optimal timing of [18F]HX4 PET images,
- to compare [18F]HX4 PET uptake with [18F]FDG PET uptake before and after treatment and
- analyze correlation with responses
Read the 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
- Being tested
- injection with [18F] HX4 and PET imaging
- Keywords
- cervix cancer, [18F] HX4 PET imaging, hypoxia, phase II trial
- Medical subject headings
- Uterine Cervical Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection with [18F] HX4 and PET imagingOther
Also called 3-[18F]fluoro- 2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol
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
| Study group | Role | What they receive |
|---|---|---|
| [18F] HX4 PET imaging | Experimental | injection with [18F] HX4 and PET imaging at baseline and after 20 Gy radiotherapy Receives: Other: injection with [18F] HX4 and PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Measured: 2 year
Secondary outcomes (8)
Observation of spatial and temporal stability of [18F] HX4 PET images
Observation of spatial and temporal stability of [18F] HX4 PET images
Measured: 2 year
Correlations with Complete Remission rates at 3 months restaging evaluation
Correlations with Complete Remission rates at 3 months restaging evaluation
Measured: 2 year
Image quality of [18F] HX4-PET at different time points
Image quality of [18F] HX4-PET at different time points
Measured: 2 year
Kinetic analysis of HX4
Kinetic analysis of HX4
Measured: 2 year
Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)
Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)
Measured: 2 year
Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes
Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes
Measured: 2 year
Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
Measured: 2 year
Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: patients did not want to participate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Lambin, prof MD PhD, Study director, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233387
- Sponsor's protocol ID
- 11-36-14/12
- Acronym
- HX4-cervix
- Status last verified
- Mar 2019
- First submitted
- 29 Feb 2012
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Cervix Cancer.
- ClinicalTrials.gov ID
- NCT02233387
- Acronym / sponsor ID
- HX4-cervix / 11-36-14/12
- Conditions
- Cervix Cancer
- Keywords
- cervix cancer, [18F] HX4 PET imaging, hypoxia, phase II trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patients did not want to participate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is:
- to determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in cervix cancer,
- to correlate the [18F]HX4 PET images with blood and tissue markers,
- to investigate the quality and optimal timing of [18F]HX4 PET images,
- to compare [18F]HX4 PET uptake with [18F]FDG PET uptake before and after treatment and
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F] HX4 PET imaging | Experimental | Other: injection with [18F] HX4 and PET imaginginjection with [18F] HX4 and PET imaging at baseline and after 20 Gy radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Recent (< 3 months) myocardial infarction
- Uncontrolled infectious disease
- Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection with [18F] HX4 and PET imagingAlso: 3-[18F]fluoro- 2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-olA 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 | Other | [18F] HX4 PET imaging |
Primary outcome
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Time frame: 2 year
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
8 secondary outcomes
Observation of spatial and temporal stability of [18F] HX4 PET images
Time frame: 2 year
Correlations with Complete Remission rates at 3 months restaging evaluation
Time frame: 2 year
Image quality of [18F] HX4-PET at different time points
Time frame: 2 year
Kinetic analysis of HX4
Time frame: 2 year
Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)
Time frame: 2 year
Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes
Time frame: 2 year
Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
Time frame: 2 year
Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
Time frame: 2 year
Results and safety
The study was stopped early (reason given: patients did not want to participate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
Related trials for Cervix Cancer
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Enrolling by invitationObservational study
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
Cervical Cancer Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Lambin, prof MD PhD study director
Maastro Clinic, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing injection with [18F] HX4 and PET imaging in people with Cervix Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: patients did not want to participate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualisation of tumor hypoxia with [18F] HX4 PET imaging (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.