Solid Tumor, AdultPhase 1NCT02717572
18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
A Phase 1 study testing Fludeoxyglucose F 18, Positron Emission Tomography and Computerized Tomography in people with Solid Tumor, Adult, run by Washington University School of Medicine at 1 site in United States.
Trial summary
In the current study, the investigators plan to expand the knowledge of Positron Emission Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent diffusion coefficients (ADC) measurements, in a broad… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Fludeoxyglucose F 18, Positron Emission Tomography and Computerized Tomography
- 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
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 5 Jun 2017
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed malignant solid tumors (local or metastatic, newly diagnosed or recurrent disease).
- Patient must have at least one lesion measuring ≥ 2.0 cm.
- 18 years of age or older.
- Ability to provide informed consent.
Who cannot join
- Cancer therapy within 30 days of baseline imaging.
- Uncontrolled intercurrent illness including, but not limited to active infections.
- Patients with insulin-dependent diabetes.
- Patients with metal devices in the body including, but not limited to metallic joint prostheses, artificial heart valves, pacemakers, and cochlear implants.
- Patients who are pregnant or nursing.
- Inability to tolerate 60 minutes of PET imaging.
- Inability to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
In the current study, the investigators plan to expand the knowledge of Positron Emission Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent diffusion coefficients (ADC) measurements, in a broad population of patients with malignant solid tumors.
- Conditions
- Solid Tumor, Adult
- Being tested
- Fludeoxyglucose F 18, Positron Emission Tomography, Computerized Tomography, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludeoxyglucose F 18Radiation
Also called FDG, 18FDG
Positron Emission TomographyDevice
Also called PET
Computerized TomographyDevice
Also called CT, CAT
Magnetic Resonance ImagingDevice
Also called MRI
| Study group | Role | What they receive |
|---|---|---|
| FDG-PET/CT and FDG-PET/MR | Experimental | * 10 mCI fludeoxyglucose IV bolus approximately 60 minutes before first PET/CT
* Immediately following PET/CT scan, the participant will be moved to PET/MR scanner
* The scans will take place at baseline and also one more time point between Day 1 and Day 7. There needs to be at least 24 hours between the baseline and repeat imaging Receives: Radiation: Fludeoxyglucose F 18; Device: Positron Emission Tomography; Device: Computerized Tomography; Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of repeated quantitative measures of FDG uptake as measured by SUVmax
-SUVmax is the maximum standardized uptake value (SUV) of the area of showing metabolic activity and this is used to show response
Measured: Completion of study (up to Day 7)
Variability of repeated quantitative measures of FDG uptake as measured by SUVpeak
-SUVpeak, which is defined as the average SUV within a 1 cubic cm volume within the region of the tumor with the highest metabolic activity
Measured: Completion of study (up to Day 7)
Repeatability of diffusion-weighted imaging on PET/MR as measured by difference in mean ADC
- DW MRI is a method of mapping the diffusion process of water within and between tissues
- Water diffusion is described quantitatively by apparent diffusion coefficients (ADC)
Measured: Completion of study (up to Day 7)
Repeatability of diffusion-weighted imaging on PET/MR as measured by differences in minimum ADC
- DW MRI is a method of mapping the diffusion process of water within and between tissues
- Water diffusion is described quantitatively by apparent diffusion coefficients (ADC)
Measured: Completion of study (up to Day 7)
Secondary outcomes (1)
Evaluation of the ratio of SUVmax and ADCmin
Measured: Completion of study (up to Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion5 Jun 2017
- Study completion5 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard L Wahl, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717572
- Sponsor's protocol ID
- 201508093
- Status last verified
- Apr 2019
- First submitted
- 17 Mar 2016
- Last updated
- 5 Apr 2019
- 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 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
- ClinicalTrials.gov ID
- NCT02717572
- Acronym / sponsor ID
- 201508093
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 23 Mar 2016 (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.
In the current study, the investigators plan to expand the knowledge of Positron Emission Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent diffusion coefficients (ADC) measurements, in a broad population of patients with malignant solid tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG-PET/CT and FDG-PET/MR | Experimental | Radiation: Fludeoxyglucose F 18, Device: Positron Emission Tomography, Device: Computerized Tomography, Device: Magnetic Resonance Imaging* 10 mCI fludeoxyglucose IV bolus approximately 60 minutes before first PET/CT * Immediately following PET/CT scan, the participant will be moved to PET/MR scanner * The scans will take place at baseline and also one more time point between Day 1 and Day 7. There needs to be at least 24 hours between the baseline and repeat imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologically confirmed malignant solid tumors (local or metastatic, newly diagnosed or recurrent disease).
- Patient must have at least one lesion measuring ≥ 2.0 cm.
- 18 years of age or older.
- Ability to provide informed consent.
Key exclusion criteria (7 listed)
- Cancer therapy within 30 days of baseline imaging.
- Uncontrolled intercurrent illness including, but not limited to active infections.
- Patients with insulin-dependent diabetes.
- Patients with metal devices in the body including, but not limited to metallic joint prostheses, artificial heart valves, pacemakers, and cochlear implants.
- Patients who are pregnant or nursing.
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 |
|---|---|---|
| Fludeoxyglucose F 18Also: FDG, 18FDG | Radiation | FDG-PET/CT and FDG-PET/MR |
| Positron Emission TomographyAlso: PET | Device | FDG-PET/CT and FDG-PET/MR |
| Computerized TomographyAlso: CT, CAT | Device | FDG-PET/CT and FDG-PET/MR |
| Magnetic Resonance ImagingAlso: MRI | Device | FDG-PET/CT and FDG-PET/MR |
Primary outcome
Variability of repeated quantitative measures of FDG uptake as measured by SUVmax
Time frame: Completion of study (up to Day 7)
-SUVmax is the maximum standardized uptake value (SUV) of the area of showing metabolic activity and this is used to show response
Variability of repeated quantitative measures of FDG uptake as measured by SUVpeak
Time frame: Completion of study (up to Day 7)
-SUVpeak, which is defined as the average SUV within a 1 cubic cm volume within the region of the tumor with the highest metabolic activity
Repeatability of diffusion-weighted imaging on PET/MR as measured by difference in mean ADC
Time frame: Completion of study (up to Day 7)
* DW MRI is a method of mapping the diffusion process of water within and between tissues * Water diffusion is described quantitatively by apparent diffusion coefficients (ADC)
Repeatability of diffusion-weighted imaging on PET/MR as measured by differences in minimum ADC
Time frame: Completion of study (up to Day 7)
* DW MRI is a method of mapping the diffusion process of water within and between tissues * Water diffusion is described quantitatively by apparent diffusion coefficients (ADC)
1 secondary outcome
Evaluation of the ratio of SUVmax and ADCmin
Time frame: Completion of study (up to Day 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Richard L Wahl, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fludeoxyglucose F 18, Positron Emission Tomography and Computerized Tomography in people with Solid Tumor, Adult, run by Washington University School of Medicine 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 7 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: finished, as of the sponsor's last update on 5 Apr 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variability of repeated quantitative measures of FDG uptake as measured by SUVmax (time frame: Completion of study (up to Day 7)). The study lists 4 primary outcomes in all. 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 5 Apr 2019.