Metastatic Malignant NeoplasmNCT05174026
18F-FDG PET-MRI for Planning and Follow-Up of Patients With Spine Tumors Treated With Spine Stereotactic Radiosurgery
A study testing Fludeoxyglucose F-18, Magnetic Resonance Imaging and Positron Emission Tomography in people with Metastatic Malignant Neoplasm and Metastatic Malignant Neoplasm in the Bone, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well 18F-FDG PET-MRI works for treatment planning in patients with spine tumors. Diagnostic procedures, such as 18F-FDG PET-MRI may help radiation oncologists plan the best treatment for spine tumors, as well as help in follow-up after radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm, Metastatic Malignant Neoplasm in the Bone
- What is being tested?
- Fludeoxyglucose F-18, Magnetic Resonance Imaging and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 20 Jun 2024
- Phase
- Interventional
- 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
- Consent to imaging study
- Presence of at least 1 lumbar vertebral body bone metastasis > 1 cm in shortest diameter and smaller than 75% of the vertebral body cross sectional area. Metastasis may be determined by pathology, or imaging appearance.
- Eligibility to receive SSRS (determined by treating radiation oncologists)
- Plan for single-fraction SSRS
- Standard-of-care spine MRI within 8 weeks of radiation therapy
- Ability to understand and willingness to sign a written informed consent document
- Non-English speaking participants will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking participants.
Who cannot join
- Absolute or relative contra-indication to MRI, including presence of a pacemaker that requires involvement of cardiology/anesthesiology during the scan
- Prior directed radiation to the involved segment
- Contra-indication to gadolinium based contrast agents (e.g., allergy, pregnancy)
- Individuals younger than 18 years
- Hardware at the treatment level or hardware affecting visualization of the involved level on MRI
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study on the Efficacy of Advanced 18F-FDG PET-MRI in Spine Stereotactic Radiosurgery
This trial studies how well 18F-FDG PET-MRI works for treatment planning in patients with spine tumors. Diagnostic procedures, such as 18F-FDG PET-MRI may help radiation oncologists plan the best treatment for spine tumors, as well as help in follow-up after radiation therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI) in spine stereotactic radiosurgery (SSRS) treatment planning compared to advanced MRI (aMRI) and conventional MRI (cMRI).
II. Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients treated with SSRS.
SECONDARY OBJECTIVES:
- Analysis of the subset of patients who eventually suffer local treatment failure to determine patterns of failure and potential predictive PET/MRI features at baseline.
II. Analysis of the subset of patients who suffer complications of SSRS (e.g., vertebral compression fracture) to determine potential predictive imaging features.
OUTLINE:
Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute, and then undergo PET-MRI over 1 hour, 30 days before radiation therapy, and 3 and 6 months after radiation therapy.
- Being tested
- Fludeoxyglucose F-18, Magnetic Resonance Imaging, Positron Emission Tomography
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludeoxyglucose F-18Other
Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo 18F-FDG PET-MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo 18F-FDG PET-MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (18F-FDG PET-MRI) | Experimental | Patients receive fludeoxyglucose F-18 IV over 1 minute, and then undergo PET-MRI over 1 hour, 30 days before radiation therapy, and 3 and 6 months after radiation therapy. Receives: Other: Fludeoxyglucose F-18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI).
Measured: up to 6 months
Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients.
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 posted30 Dec 2021
- Study start30 Nov 2018
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Behrang Amini, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174026
- Sponsor's protocol ID
- 2017-0788
- Other IDs
- NCI-2019-08261, 2017-0788
- Status last verified
- Jun 2024
- First submitted
- 10 Sep 2021
- Last updated
- 25 Jun 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Efficacy of Advanced 18F-FDG PET-MRI in Spine Stereotactic Radiosurgery
- ClinicalTrials.gov ID
- NCT05174026
- Acronym / sponsor ID
- 2017-0788
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 30 Dec 2021 (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 trial studies how well 18F-FDG PET-MRI works for treatment planning in patients with spine tumors. Diagnostic procedures, such as 18F-FDG PET-MRI may help radiation oncologists plan the best treatment for spine tumors, as well as help in follow-up after radiation therapy.
Detailed description
PRIMARY OBJECTIVES:
- Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI) in spine stereotactic radiosurgery (SSRS) treatment planning compared to advanced MRI (aMRI) and conventional MRI (cMRI).
II. Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients treated with SSRS.
SECONDARY OBJECTIVES:
- Analysis of the subset of patients who eventually suffer local treatment failure to determine patterns of failure and potential predictive PET/MRI features at baseline.
II. Analysis of the subset of patients who suffer complications of SSRS (e.g., vertebral compression fracture) to determine potential predictive imaging features.
OUTLINE:
Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute, and then undergo PET-MRI over 1 hour, 30 days before radiation therapy, and 3 and 6 months after radiation therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (18F-FDG PET-MRI) | Experimental | Other: Fludeoxyglucose F-18, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission TomographyPatients receive fludeoxyglucose F-18 IV over 1 minute, and then undergo PET-MRI over 1 hour, 30 days before radiation therapy, and 3 and 6 months after radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consent to imaging study
- Presence of at least 1 lumbar vertebral body bone metastasis > 1 cm in shortest diameter and smaller than 75% of the vertebral body cross sectional area. Metastasis may be determined by pathology, or imaging appearance.
- Eligibility to receive SSRS (determined by treating radiation oncologists)
- Plan for single-fraction SSRS
- Standard-of-care spine MRI within 8 weeks of radiation therapy
Key exclusion criteria (6 listed)
- Absolute or relative contra-indication to MRI, including presence of a pacemaker that requires involvement of cardiology/anesthesiology during the scan
- Prior directed radiation to the involved segment
- Contra-indication to gadolinium based contrast agents (e.g., allergy, pregnancy)
- Individuals younger than 18 years
- Hardware at the treatment level or hardware affecting visualization of the involved level on 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 |
|---|---|---|
| Fludeoxyglucose F-18Also: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18Given IV | Other | Diagnostic (18F-FDG PET-MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo 18F-FDG PET-MRI | Procedure or surgery | Diagnostic (18F-FDG PET-MRI) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo 18F-FDG PET-MRI | Procedure or surgery | Diagnostic (18F-FDG PET-MRI) |
Primary outcome
Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI).
Time frame: up to 6 months
Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients.
Time frame: up to 6 months
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 25 Jun 2024.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Behrang Amini principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fludeoxyglucose F-18, Magnetic Resonance Imaging and Positron Emission Tomography in people with Metastatic Malignant Neoplasm and Metastatic Malignant Neoplasm in the Bone, run by M.D. Anderson Cancer Center 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 7 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: finished, as of the sponsor's last update on 25 Jun 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 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?
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?
Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI). (time frame: up to 6 months). The study lists 2 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 25 Jun 2024.