Metastatic CancerNCT06630845
Comparison of Whole Body DWI to FDG PET
A study testing Fluorodeoxyglucose F18, Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI) and Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI) in people with Metastatic Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Fluorodeoxyglucose F18, Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI) and Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 30 Apr 2029
- 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
- Age ≥ 18 years.
- Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Diagnosis of metastatic cancer.
Who cannot join
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Individuals with contraindications to MRI. This will be determined through review of the University of California, San Francisco (UCSF) magnetic resonance imaging (MRI) screening form by qualified site personnel.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Comparison of Whole Body DWI to FDG PET Using PET/MRI
This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Correlation of DWI and FDG to detect disease.
SECONDARY OBJECTIVE:
- Inter-reader variability of DWI interpretation by region.
OUTLINE:
Participants will be imaged at a single timepoint using whole body DWI concurrent with FDG PET/MRI within 60 days of receiving a non-FDG PET (either PET/CT or PET/MRI). There will be an optional PET/MRI performed within six months of the original study. Participants will be followed up through a medical records review for up to two years.
- Conditions
- Metastatic Cancer
- Being tested
- Fluorodeoxyglucose F18, Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI), Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI), General Electric (GE) SIGNA PET/MR
- Keywords
- Imaging Study
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorodeoxyglucose F18Drug
Also called Fludeoxyglucose F18 (FDG), 2-deoxy-2-[fluorine-18]fluoro-D-glucose, Fluorodeoxyglucose
Given IV as part of routine imaging
Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)Procedure or surgery
Also called PET/MRI
Imaging procedure
Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)Procedure or surgery
Also called WB-MRI-DWI
Imaging procedure done concurrently with PET/MRI
General Electric (GE) SIGNA PET/MRDevice
Also called GE SIGNA PET/MR, SIGNA PET/MR
Imaging device
| Study group | Role | What they receive |
|---|---|---|
| Whole Body DWI plus FDG PET/MRI | Experimental | Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months. Receives: Drug: Fluorodeoxyglucose F18; Procedure: Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI); Procedure: Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI); Device: General Electric (GE) SIGNA PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of lesions characterized as positive
The overall proportion of lesions that will be characterized as positive on whole body (WB) diffusion weight imaging (DWI) and FDG PET.
Measured: Up to 6 months
Secondary outcomes (1)
Inter-reader variability of diffusion weight imaging (DWI) interpretation
Inter-reader variability is the degree of agreement among independent observers who rate, code, or assess the same image. Eighteen regions per participant will be scored by two blinded readers at each time point and assessed for the presence of DWI positive disease (local disease; nodal disease: pelvic, retroperitoneal, thoracic, and other; osseous disease: skull, ribs and sternum, cervical/thoracic/lumbar spine, right/left pelvis, sacrum and upper/lower extremities; visceral disease: lung, liver, and other). Scores range from 0 to 1 with 1 being excellent agreement between the two readers.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start6 Feb 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Abdominal Radiology, GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Thomas A Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630845
- Sponsor's protocol ID
- 24926
- Other IDs
- NCI-2024-09278
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Whole Body DWI to FDG PET Using PET/MRI
- ClinicalTrials.gov ID
- NCT06630845
- Acronym / sponsor ID
- 24926
- Conditions
- Metastatic Cancer
- Keywords
- Imaging Study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Society of Abdominal Radiology, GE Healthcare
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 8 Oct 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.
This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer.
Detailed description
PRIMARY OBJECTIVE:
- Correlation of DWI and FDG to detect disease.
SECONDARY OBJECTIVE:
- Inter-reader variability of DWI interpretation by region.
OUTLINE:
Participants will be imaged at a single timepoint using whole body DWI concurrent with FDG PET/MRI within 60 days of receiving a non-FDG PET (either PET/CT or PET/MRI). There will be an optional PET/MRI performed within six months of the original study. Participants will be followed up through a medical records review for up to two years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Body DWI plus FDG PET/MRI | Experimental | Drug: Fluorodeoxyglucose F18, Procedure: Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI), Procedure: Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI), Device: General Electric (GE) SIGNA PET/MRParticipants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Diagnosis of metastatic cancer.
Key exclusion criteria (2 listed)
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Individuals with contraindications to MRI. This will be determined through review of the University of California, San Francisco (UCSF) magnetic resonance imaging (MRI) screening form by qualified site personnel.
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 |
|---|---|---|
| Fluorodeoxyglucose F18Also: Fludeoxyglucose F18 (FDG), 2-deoxy-2-[fluorine-18]fluoro-D-glucose, FluorodeoxyglucoseGiven IV as part of routine imaging | Drug | Whole Body DWI plus FDG PET/MRI |
| Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)Also: PET/MRIImaging procedure | Procedure or surgery | Whole Body DWI plus FDG PET/MRI |
| Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)Also: WB-MRI-DWIImaging procedure done concurrently with PET/MRI | Procedure or surgery | Whole Body DWI plus FDG PET/MRI |
| General Electric (GE) SIGNA PET/MRAlso: GE SIGNA PET/MR, SIGNA PET/MRImaging device | Device | Whole Body DWI plus FDG PET/MRI |
Primary outcome
Proportion of lesions characterized as positive
Time frame: Up to 6 months
The overall proportion of lesions that will be characterized as positive on whole body (WB) diffusion weight imaging (DWI) and FDG PET.
1 secondary outcome
Inter-reader variability of diffusion weight imaging (DWI) interpretation
Time frame: Up to 6 months
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 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
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.
Thomas A Hope, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorodeoxyglucose F18, Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI) and Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI) in people with Metastatic Cancer, run by University of California, San Francisco at 1 site in United States.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. 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 United States. 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?
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?
Proportion of lesions characterized as positive (time frame: Up to 6 months). 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 20 Oct 2026.