CancerPhase 2NCT00375830
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
A Phase 2 study testing Bone scan, 99mTc-methyl diphosphonate and Positron Emission Tomography (PET) scan in people with Cancer, run by Stanford University at 1 site in United States.
Trial summary
This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Bone scan, 99mTc-methyl diphosphonate and Positron Emission Tomography (PET) scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to 14 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- ≥ 18 years old at the time of the drug administration
- ≥ Stage 3 breast cancer OR ≥ stage 2 prostate cancer OR prostate-specific antigen (PSA) > 10 micrograms/L OR recurrent breast or prostate cancer
- Capable of complying with study procedures
- Able to remain still for duration of imaging procedure (about one hour)
- Written informed consent
Who cannot join
- Pregnant or nursing
- Metallic implants that contraindicate MRI
- Renal function impairment that contraindicates MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
Read the detailed description
Eligible participants had previously received a bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP) as part of their regular medical care.
18F-NaF and 18F-FDG are radioactive substances (radiolabels) that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI). PET/WBMRI is a combination procedure that combines the detailed PET images of areas inside the body from PET with the WBMRI scans, and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. It is not yet known whether 18F-NaF/18F-FDG PET/WBMRI is better than standard imaging methods in detecting skeletal metastases.
Eligible participants diagnosed with breast/prostate cancers and who have had 99mTc MDP bone scanning as part of their routine care are recruited and enrolled. Participants then receive an 18F-NaF/18F-FDG positron emission tomography (PET)/ WBMRI combination scan.
The PET/MRI scans will be interpreted by 2 American Board Nuclear Medicine (ABNM)-certified physicians and 2 American Board of Radiology (ABR)-certified radiologists, all with significant clinical experience, who are blinded to the subjects' medical history and the results of other imaging modalities.
The scans will be analyzed and compared against each other, with a consensus read will be obtained for each scan. Characterization of lesions as true-positive, true-negative, false-positive or false-negative will be done through a combination of clinical follow-up, imaging follow-up and/or histopathology findings. An overall diagnosis based on each scan will be determined on a 5-point scale (1=benign, 2=likely benign, 3=uncertain, 4=likely malignant, 5=malignant) to conduct a receiver operating characteristic (ROC) analysis.
If the diagnosis is positive for metastases on any of the scans, the investigator will identify the number of lesions and locations of positivity, and record this information.
Clinical is obtained at about 12 months after the initial scans.
- Conditions
- Cancer
- Being tested
- Bone scan, 99mTc-methyl diphosphonate, Positron Emission Tomography (PET) scan, 18F-Fludeoxyglucose (18F-FDG), Computed Tomography (CT) scan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone scanProcedure or surgery
Also called Bone scintigraphy
Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonateDrug
Also called 99mTc-methylene diphosphonate, Technetium 99mTc medronate, 99mTc-MDP, t99-MDP
Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scanProcedure or surgery
Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG)Drug
Also called 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, 2-F18-Fluoro-2-deoxyglucose, 18F 2-Fluoro-2-deoxy-D-Glucose
Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scanProcedure or surgery
Also called Computerized Axial Tomograph (CAT) scan, Computer-aided Tomography (CAT) scan
Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF)Drug
Also called 18F-Sodium Fluorine
Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scanProcedure or surgery
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.
Gadopentetate dimeglumineDrug
Also called Magnevist
A gadolinium-based contrast agent for MRI
GadofosvesetDrug
Also called Ablavar
A gadolinium-based contrast agent for MRI
GadobutrolDrug
Also called Gadavist
A gadolinium-based contrast agent for MRI
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans | Experimental | Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the combined 18F-NaF CT \& 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans. Receives: Procedure: Bone scan; Drug: 99mTc-methyl diphosphonate; Procedure: Positron Emission Tomography (PET) scan; Drug: 18F-Fludeoxyglucose (18F-FDG); Procedure: Computed Tomography (CT) scan; Drug: 18F-Sodium Fluoride (18F-NaF); Drug: Gadopentetate dimeglumine |
| Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans | Experimental | Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan. Receives: Procedure: Bone scan; Drug: 99mTc-methyl diphosphonate; Procedure: Positron Emission Tomography (PET) scan; Drug: 18F-Fludeoxyglucose (18F-FDG); Procedure: Computed Tomography (CT) scan; Drug: 18F-Sodium Fluoride (18F-NaF); Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan; Drug: Gadofosveset; Drug: Gadobutrol |
| Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan | Experimental | Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure. Receives: Procedure: Bone scan; Drug: 99mTc-methyl diphosphonate; Procedure: Positron Emission Tomography (PET) scan; Drug: 18F-Fludeoxyglucose (18F-FDG); Drug: 18F-Sodium Fluoride (18F-NaF); Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan; Drug: Gadofosveset; Drug: Gadobutrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF > 99mTc-MDP"), the same between both scans ("18F-NaF = 99mTc-MDP"), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF < 99mTc-MDP").
Measured: 30 days
Secondary outcomes (11)
Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.
Measured: 30 days
Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was > 18F-NaF PET/CT; equal to 18F-NaF PET/CT; or < 18F-NaF PET/CT. The outcome result is represented as a number without dispersion.
8 analyzed 5 2
1
Measured: 30 days
Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was > 18F-FDG PET/CT; equal to to 18F-FDG PET/CT; or < 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.
Measured: 30 days
Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT
The ability of 18F-sodium fluoride (NaF) and 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) to detect osseous (skeletal) metastases was assessed. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of Cohort 1 participants for whom osseous metastases were detected, a number without dispersion.
Measured: 30 days
Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI).
- Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants.
- PPV is the probability that participants with a positive screening test truly have the disease.
- Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined.
Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Measured: 30 days
Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Measured: 30 days
Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Measured: 30 days
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Measured: 30 days
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Measured: 30 days
Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion.
Measured: 30 days
Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startJan 2006
- Primary completion17 Apr 2017
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375830
- Sponsor's protocol ID
- IRB-03778
- Other IDs
- 96754, BONE0001
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2006
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iagaru A, Young P, Mittra E, Dick DW, Herfkens R, Gambhir SS. Pilot prospective evaluation of 99mTc-MDP scintigraphy, 18F NaF PET/CT, 18F FDG PET/CT and whole-body MRI for detection of skeletal metastases. Clin Nucl Med. 2013 Jul;38(7):e290-6. doi: 10.1097/RLU.0b013e3182815f64.
PubMed 23455520Minamimoto R, Loening A, Jamali M, Barkhodari A, Mosci C, Jackson T, Obara P, Taviani V, Gambhir SS, Vasanawala S, Iagaru A. Prospective Comparison of 99mTc-MDP Scintigraphy, Combined 18F-NaF and 18F-FDG PET/CT, and Whole-Body MRI in Patients with Breast and Prostate Cancer. J Nucl Med. 2015 Dec;56(12):1862-8. doi: 10.2967/jnumed.115.162610. Epub 2015 Sep 24.
PubMed 26405167Iagaru A, Minamimoto R, Jamali M, Barkodhodari A, Gambhir SS, Vasanawala S. Imaging patients with breast and prostate cancers using combined 18F NaF/18F FDG and TOF simultaneous PET/ MRI. EJNMMI Phys. 2015 Dec;2(Suppl 1):A65. doi: 10.1186/2197-7364-2-S1-A65. No abstract available.
PubMed 26956325Sonni I, Minamimoto R, Baratto L, Gambhir SS, Loening AM, Vasanawala SS, Iagaru A. Simultaneous PET/MRI in the Evaluation of Breast and Prostate Cancer Using Combined Na[18F] F and [18F]FDG: a Focus on Skeletal Lesions. Mol Imaging Biol. 2020 Apr;22(2):397-406. doi: 10.1007/s11307-019-01392-9.
PubMed 31236756
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
- ClinicalTrials.gov ID
- NCT00375830
- Acronym / sponsor ID
- IRB-03778
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- 17 Apr 2017 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Posted 8 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
Detailed description
Eligible participants had previously received a bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP) as part of their regular medical care.
18F-NaF and 18F-FDG are radioactive substances (radiolabels) that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI). PET/WBMRI is a combination procedure that combines the detailed PET images of areas inside the body from PET with the WBMRI scans, and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. It is not yet known whether 18F-NaF/18F-FDG PET/WBMRI is better than standard imaging methods in detecting skeletal metastases.
Eligible participants diagnosed with breast/prostate cancers and who have had 99mTc MDP bone scanning as part of their routine care are recruited and enrolled. Participants then receive an 18F-NaF/18F-FDG positron emission tomography (PET)/ WBMRI combination scan.
The PET/MRI scans will be interpreted by 2 American Board Nuclear Medicine (ABNM)-certified physicians and 2 American Board of Radiology (ABR)-certified radiologists, all with significant clinical experience, who are blinded to the subjects' medical history and the results of other imaging modalities.
The scans will be analyzed and compared against each other, with a consensus read will be obtained for each scan. Characterization of lesions as true-positive, true-negative, false-positive or false-negative will be done through a combination of clinical follow-up, imaging follow-up and/or histopathology findings. An overall diagnosis based on each scan will be determined on a 5-point scale (1=benign, 2=likely benign, 3=uncertain, 4=likely malignant, 5=malignant) to conduct a receiver operating characteristic (ROC) analysis.
If the diagnosis is positive for metastases on any of the scans, the investigator will identify the number of lesions and locations of positivity, and record this information.
Clinical is obtained at about 12 months after the initial scans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans | Experimental | Procedure: Bone scan, Drug: 99mTc-methyl diphosphonate, Procedure: Positron Emission Tomography (PET) scan, Drug: 18F-Fludeoxyglucose (18F-FDG), Procedure: Computed Tomography (CT) scan, Drug: 18F-Sodium Fluoride (18F-NaF), Drug: Gadopentetate dimegluminePreliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the combined 18F-NaF CT \& 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans. |
| Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans | Experimental | Procedure: Bone scan, Drug: 99mTc-methyl diphosphonate, Procedure: Positron Emission Tomography (PET) scan, Drug: 18F-Fludeoxyglucose (18F-FDG), Procedure: Computed Tomography (CT) scan, Drug: 18F-Sodium Fluoride (18F-NaF), Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan, Drug: Gadofosveset, Drug: GadobutrolAssessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan. |
| Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan | Experimental | Procedure: Bone scan, Drug: 99mTc-methyl diphosphonate, Procedure: Positron Emission Tomography (PET) scan, Drug: 18F-Fludeoxyglucose (18F-FDG), Drug: 18F-Sodium Fluoride (18F-NaF), Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan, Drug: Gadofosveset, Drug: GadobutrolAssessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years old at the time of the drug administration
- ≥ Stage 3 breast cancer OR ≥ stage 2 prostate cancer OR prostate-specific antigen (PSA) > 10 micrograms/L OR recurrent breast or prostate cancer
- Capable of complying with study procedures
- Able to remain still for duration of imaging procedure (about one hour)
- Written informed consent
Key exclusion criteria (3 listed)
- Pregnant or nursing
- Metallic implants that contraindicate MRI
- Renal function impairment that contraindicates MRI
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 |
|---|---|---|
| Bone scanAlso: Bone scintigraphyScan to diagnose a number of bone conditions including cancer or metastasis | Procedure or surgery | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan |
| 99mTc-methyl diphosphonateAlso: 99mTc-methylene diphosphonate, Technetium 99mTc medronate, 99mTc-MDP, t99-MDPRadiolabel for bone scan procedures | Drug | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan |
| Positron Emission Tomography (PET) scanScan to detect gamma rays emitted by a positron-emitting radioligand such as 18F | Procedure or surgery | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan |
| 18F-Fludeoxyglucose (18F-FDG)Also: 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, 2-F18-Fluoro-2-deoxyglucose, 18F 2-Fluoro-2-deoxy-D-GlucoseRadiolabel for positron emission tomography scan procedures | Drug | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan |
| Computed Tomography (CT) scanAlso: Computerized Axial Tomograph (CAT) scan, Computer-aided Tomography (CAT) scanScan to detect \& analyze X-rays | Procedure or surgery | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans |
| 18F-Sodium Fluoride (18F-NaF)Also: 18F-Sodium FluorineRadiolabel for CT and PET scans, \& as a contrast agent for MRI scans. | Drug | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan |
| Whole Body Magnetic Resonance Imaging (WB-MRI) scanWhole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body. | Procedure or surgery | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan |
| Gadopentetate dimeglumineAlso: MagnevistA gadolinium-based contrast agent for MRI | Drug | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans |
| GadofosvesetAlso: AblavarA gadolinium-based contrast agent for MRI | Drug | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan |
| GadobutrolAlso: GadavistA gadolinium-based contrast agent for MRI | Drug | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans, Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan |
Primary outcome
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
Time frame: 30 days
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF > 99mTc-MDP"), the same between both scans ("18F-NaF = 99mTc-MDP"), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF < 99mTc-MDP").
11 secondary outcomes
Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
Time frame: 30 days
Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
Time frame: 30 days
Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
Time frame: 30 days
Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT
Time frame: 30 days
Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
Time frame: 30 days
Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions
Time frame: 30 days
Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions
Time frame: 30 days
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI
Time frame: 30 days
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy
Time frame: 30 days
Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
Time frame: 30 days
Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23455520Iagaru A, Young P, Mittra E, Dick DW, Herfkens R, Gambhir SS. Pilot prospective evaluation of 99mTc-MDP scintigraphy, 18F NaF PET/CT, 18F FDG PET/CT and whole-body MRI for detection of skeletal metastases. Clin Nucl Med. 2013 Jul;38(7):e290-6. doi: 10.1097/RLU.0b013e3182815f64.
- Results publication: PubMed 26405167Minamimoto R, Loening A, Jamali M, Barkhodari A, Mosci C, Jackson T, Obara P, Taviani V, Gambhir SS, Vasanawala S, Iagaru A. Prospective Comparison of 99mTc-MDP Scintigraphy, Combined 18F-NaF and 18F-FDG PET/CT, and Whole-Body MRI in Patients with Breast and Prostate Cancer. J Nucl Med. 2015 Dec;56(12):1862-8. doi: 10.2967/jnumed.115.162610. Epub 2015 Sep 24.
- Results publication: PubMed 26956325Iagaru A, Minamimoto R, Jamali M, Barkodhodari A, Gambhir SS, Vasanawala S. Imaging patients with breast and prostate cancers using combined 18F NaF/18F FDG and TOF simultaneous PET/ MRI. EJNMMI Phys. 2015 Dec;2(Suppl 1):A65. doi: 10.1186/2197-7364-2-S1-A65. No abstract available.
- Results publication: PubMed 31236756Sonni I, Minamimoto R, Baratto L, Gambhir SS, Loening AM, Vasanawala SS, Iagaru A. Simultaneous PET/MRI in the Evaluation of Breast and Prostate Cancer Using Combined Na[18F] F and [18F]FDG: a Focus on Skeletal Lesions. Mol Imaging Biol. 2020 Apr;22(2):397-406. doi: 10.1007/s11307-019-01392-9.
- 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.
Andrei Iagaru, MD principal investigator
Stanford University
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 Bone scan, 99mTc-methyl diphosphonate and Positron Emission Tomography (PET) scan in people with Cancer, run by Stanford University 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 5 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: finished, as of the sponsor's last update on 12 Dec 2023. 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 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?
Yes. Results are posted in the registry (first posted 8 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375830, which also lists 4 linked publications.
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 12 Dec 2023.