Fluorodeoxyglucose F18DEPLETENCT06232889
Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization
A study testing Deuterium Glucose Metabolic Imaging with MRI spectroscopy in people with Fluorodeoxyglucose F18 and Phosphoric Monoester Hydrolases, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), is a liver-directed therapy for patients suffering from hepatic metastases. As SIRT is a liver-directed treatment, only patients with liver-only or liver-dominant disease are eligible for treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluorodeoxyglucose F18, Phosphoric Monoester Hydrolases, Phosphoric Diester Hydrolases
- What is being tested?
- Deuterium Glucose Metabolic Imaging with MRI spectroscopy
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years)
- Referred for SIRT and deemed eligible by the multidisciplinary tumor board
- Size of at least one liver metastasis ≥ 1 cm on contrast enhanced CT / MRI (measurable according to RECIST 1.1) and 18FDG-avid metastatic liver disease (uptake > healthy liver uptake; measurable according to PERCIST)
- Written informed consent
Who cannot join
- Patients having FDG-negative disease (according to PERCIST)
- Patients with diabetes mellitus
- Patients having a general contra-indication for SIRT
- Patients with contra-indications for 7T MR scanning
- Patient unable to complete study scan (laying still for a long time)
- Patient unable or incapable to follow study proceedings
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, 3508 GA
Arthur J.A.T. Braat, M.D. Ph.D., +31887558855, a.j.a.t.braat@umcutrecht.nl
About this study
Official title: Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study
Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), is a liver-directed therapy for patients suffering from hepatic metastases. As SIRT is a liver-directed treatment, only patients with liver-only or liver-dominant disease are eligible for treatment. FDG-PET/CT is known to outperform conventional anatomical imaging modalities (CT or MRI) for treatment response assessment, also being of prognostic value. Subsequently following SIRT, patients are restaged with FDG-PET/CT. However, optimal timing of restaging following treatment is unknown (most commonly after 1 or 3 months, according to local institutional guidelines). More importantly, intrinsic resolution of FDG-PET/CT limits its utility in patients with small metastases, as image quality is worsened by high background noise, due to physiologic FDG uptake / metabolism in normal liver parenchyma. Additionally, FDG as radiopharmaceutical increases additional radiation burden to patients. This study will investigate the potential of metabolic MRI (7T MRI), non-invasively imaging metabolites using X-nuclei (e.g. 31P MRSI) and more importantly, the application of Deuterium Metabolic Imaging (DMI) with non-radioactive deuterated glucose, as a potential alternative over FDG-PET/CT.
- Being tested
- Deuterium Glucose Metabolic Imaging with MRI spectroscopy
- Keywords
- FDG-PET, 31P spectroscopy, MRI, Deuterium Metabolic Imaging, SIRT, TARE, Radioembolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterium Glucose Metabolic Imaging with MRI spectroscopyDiagnostic test
MRI spectroscopy of the liver, following ingestion of 20 mg deuterium glucose p.o., prior to and after radioembolization treatment for mCRC
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm feasibility of DMI for intrahepatic tumor detection.
Image quality comparison between DMI and FDG-PET/CT, defined as technical performance (e.g. signal-to-noise and tumor-to-liver ratios) and intrahepatic lesion detection.
Measured: 1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluorodeoxyglucose F18Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Braat, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232889
- Sponsor's protocol ID
- DEPLETE
- Acronym
- DEPLETE
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study
- ClinicalTrials.gov ID
- NCT06232889
- Acronym / sponsor ID
- DEPLETE / DEPLETE
- Keywords
- FDG-PET, 31P spectroscopy, MRI, Deuterium Metabolic Imaging, SIRT, TARE, Radioembolization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 31 Jan 2024 (actual)
- 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.
Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), is a liver-directed therapy for patients suffering from hepatic metastases. As SIRT is a liver-directed treatment, only patients with liver-only or liver-dominant disease are eligible for treatment. FDG-PET/CT is known to outperform conventional anatomical imaging modalities (CT or MRI) for treatment response assessment, also being of prognostic value. Subsequently following SIRT, patients are restaged with FDG-PET/CT. However, optimal timing of restaging following treatment is unknown (most commonly after 1 or 3 months, according to local institutional guidelines). More importantly, intrinsic resolution of FDG-PET/CT limits its utility in patients with small metastases, as image quality is worsened by high background noise, due to physiologic FDG uptake / metabolism in normal liver parenchyma. Additionally, FDG as radiopharmaceutical increases additional radiation burden to patients. This study will investigate the potential of metabolic MRI (7T MRI), non-invasively imaging metabolites using X-nuclei (e.g. 31P MRSI) and more importantly, the application of Deuterium Metabolic Imaging (DMI) with non-radioactive deuterated glucose, as a potential alternative over FDG-PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years)
- Referred for SIRT and deemed eligible by the multidisciplinary tumor board
- Size of at least one liver metastasis ≥ 1 cm on contrast enhanced CT / MRI (measurable according to RECIST 1.1) and 18FDG-avid metastatic liver disease (uptake > healthy liver uptake; measurable according to PERCIST)
- Written informed consent
Key exclusion criteria (6 listed)
- Patients having FDG-negative disease (according to PERCIST)
- Patients with diabetes mellitus
- Patients having a general contra-indication for SIRT
- Patients with contra-indications for 7T MR scanning
- Patient unable to complete study scan (laying still for a long time)
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 |
|---|---|---|
| Deuterium Glucose Metabolic Imaging with MRI spectroscopyMRI spectroscopy of the liver, following ingestion of 20 mg deuterium glucose p.o., prior to and after radioembolization treatment for mCRC | Diagnostic test | – |
Primary outcome
To confirm feasibility of DMI for intrahepatic tumor detection.
Time frame: 1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.
Image quality comparison between DMI and FDG-PET/CT, defined as technical performance (e.g. signal-to-noise and tumor-to-liver ratios) and intrahepatic lesion detection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deuterium Glucose Metabolic Imaging with MRI spectroscopy in people with Fluorodeoxyglucose F18 and Phosphoric Monoester Hydrolases, run by UMC Utrecht 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 31 Jan 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To confirm feasibility of DMI for intrahepatic tumor detection. (time frame: 1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.). 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 31 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.