Prostate-specific Membrane Antigen Positive TumorsNCT02978586
A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors
An observational study of Prostate-specific Membrane Antigen Positive Tumors and Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if positron emission tomography/ magnetic resonance imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an investigational radioactive drug called [Ga-68]PSMA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate-specific Membrane Antigen Positive Tumors, Prostate Cancer, Breast Cancer
- What is being tested?
- [Ga-68]PSMA PET/MR
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to 25 Oct 2019
- Phase
- Observational
- 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
Study population: Patients diagnosed with tumors expressing PSMA including prostate cancer, breast cancer, lung cancer, renal cancer and other tumor types [Ga-68]PSMA PET/MRI known to express PSMA
Who may be able to join
- Patients with PSMA-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express PSMA
- Patients able to tolerate PET/MRI scans
- Informed consent must be given and signed
Who cannot join
- Subjects who do not meet the above mentioned inclusion criteria
- Subjects who refuse to give and/or sign the informed consent
- Patients who have a history of serious adverse events related to a previous MRI or PET/CT
- Patients who are unable to undergo MRI scanning due to exclusion by institutional MRI restriction policies as mentioned in the standard institutional MRI informed consent form
- Patients who are currently pregnant or breast feeding. A pregnancy test within 72 hours of the first PET/MRI will be performed.
- Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks.
- Renal insufficiency: elevated Creatinine and/or Glomerular Filtration Rate (GFR)<40ml/min/1.7sqm (exclusion criterion only for contrast enhanced MRI)
- Patients with a known allergy against any component of the contrast enhancing MR agent will not receive MR contrast agents. (exclusion criterion only for contrast enhanced MRI)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
The purpose of this study is to see if positron emission tomography/ magnetic resonance imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an investigational radioactive drug called [Ga-68]PSMA.
Read the detailed description
Primary Objective
The primary objective of this pilot imaging study is to determine the feasibility of using positron emission tomography/ magnetic resonance (PET/MR) with [Ga-68] prostate-specific membrane antigen (PSMA) for staging and treatment monitoring of PSMA expressing tumors. [Ga-68]PSMA PET/MR findings will be compared with standard of care imaging, patient follow up, and histopathology if available. [Ga-68]PSMA PET/MR will not be used to change the patients' treatment plan. Investigators will assess PET/MR test-retest reproducibility and compare baseline [Ga-68]PSMA PET/MR with PET/MR after initiation (within 2-6 weeks) of therapy and evaluate if [Ga-68]PSMA is a suitable biomarker for treatment monitoring and assessment of early treatment response.
Secondary Objectives
- To compare early changes in PET biomarker ([Ga-68]PSMA) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response).
- To compare changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy.
- To compare results from multi-parametric MR imaging with [Ga-68]PSMA uptake.
- To assess combinations of quantitative PET and MRI metrics.
Study Design Patients, who enroll in this study, will undergo a baseline [Ga-68]PSMA PET/MR to assess the level of [Ga-68]PSMA tumor uptake. Patients with positive [Ga-68]PSMA tumor uptake (defined as [Ga-68]PSMA uptake twice the background activity) who are receiving systemic therapy will undergo a further [Ga-68]PSMA PET/MR 2-6 weeks after start of treatment. Patients with positive [Ga-68]PSMA tumor uptake will also be offered to participate in a test- retest study with a 2nd [Ga-68]PSMA PET/MR prior to treatment. Patients will therefore undergo a maximum of three [Ga-68]PSMA PET/MR imaging procedures. The first two test-retest Ga-PSMA-PET/MRI will be performed on separate days to allow for radioactive decay. There will be no other (e.g. clinically indicated) PET scan performed on the same day of [Ga-68]PSMA-PET/MRI.
- Conditions
- Prostate-specific Membrane Antigen Positive Tumors, Prostate Cancer, Breast Cancer, Lung Cancer
- Being tested
- [Ga-68]PSMA PET/MR
- Keywords
- PSMA, PET/MRI
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[Ga-68]PSMA PET/MRDevice
Also called PET/MRI
All participants will undergo at least 1 baseline [Ga-68]PSMA PET/MR. If participants test positive for [Ga-68]PSMA tumor uptake, they will under up to 2 additional scans
| Study group | Role | What they receive |
|---|---|---|
| [Ga-68]PSMA PET/MR | Up to 3 experimental PET/MRI scans will be performed to determine the level of [Ga-68]PSMA tumor uptake Receives: Device: [Ga-68]PSMA PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
The outcome measure for the statistical analysis of the test-retest reproducibility will be concordance analysis of standard uptake values (SUVs) between the 2 baseline scans
Measured: Up to 6 weeks after beginning treatment
Secondary outcomes (7)
Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI)
Morphologic imaging will be performed based on standard of care imaging protocols for anatomic detail and localization. Quantitative analysis will include Diffusion weighted imaging (DWI) and Dynamic contrast enhanced MRI (DCE-MRI)
Measured: Up to 6 weeks after beginning treatment
Ability of PET/MRI to measure changes in PET biomarker [Ga-68]PSMA) tumor uptake after initiation of therapy
A region of interest (ROI) will be placed in tumor lesions on the digital PET images in order to obtain Standardized Uptake Values (SUV) and/or time activity curves (TACs).
Relative and absolute differences in tumor SUVs between pre-treatment PET vs. PET after initiation of therapy will be calculated. These differences in [Ga-68]PSMA tumor uptake will be compared with treatment response at completion of therapy (prediction of treatment response).
Measured: Up to 6 weeks after beginning treatment
Changes in MR signal intensities after initiation of therapy
Standard morphologic imaging will be obtained in a target area harboring tumor tissue before and after treatment. Quantitative parameters will be obtained in the respective techniques by drawing a region of interest (ROI) in the tumor lesions using dedicated post processing software and interactive workstations. Relative and absolute differences in tumor signal intensities and quantitative parameters will be calculated between pre-treatment PET vs. PET after initiation of therapy. These differences will be compared with treatment response at completion of therapy (prediction of treatment response) as assessed by standard of care imaging
Measured: Up to 6 weeks after beginning treatment
Comparison of early changes in PET biomarker ([Ga68]PSMA) tumor uptake with treatment response assessed at completion of therapy
Relative and absolute differences in tumor SUVs between pre-treatment PET vs. PET after initiation of therapy will be compared with treatment response at completion of therapy.
Measured: Up to 6 weeks after beginning treatment
Comparison of changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy
Relative and absolute differences in tumor MRI signal intensities and quantitative parameters as described above between pre-treatment PET vs. PET after initiation of therapy will be compared with treatment response at completion of therapy.
Measured: Up to 6 weeks after beginning treatment
Comparison of results from multi-parametric MR imaging with [Ga-68]PSMA tumor uptake
Changes of tumor Ga68-PSMA uptake between baseline and during treatment will be compared with changes in MR multiparametric imaging (e.g. apparent diffusion coefficient (ADC) maps, MR perfusion parameters, changes in T2* maps, etc.). The ability of each PET and MR parameter will be assessed for the ability to predict treatment response.
Measured: Up to 6 weeks after beginning treatment
Assessment of combinations of quantitative PET and MRI metrics
Investigators will assess combinations of quantitative PET and MRI metrics regarding their ability to characterize tumors and predict treatment response. Advanced feature extraction and pattern recognition methods will be used to find a combination of fused MRI and PET features that are correlated with disease signature.
Measured: Up to 6 weeks after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start14 Mar 2018
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate-specific Membrane Antigen Positive TumorsStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Avril, MD, Principal investigator, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978586
- Sponsor's protocol ID
- CASE7Y16
- Status last verified
- May 2021
- First submitted
- 22 Nov 2016
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors
- ClinicalTrials.gov ID
- NCT02978586
- Acronym / sponsor ID
- CASE7Y16
- Conditions
- Prostate-specific Membrane Antigen Positive Tumors, Prostate Cancer, Breast Cancer, Lung Cancer
- Keywords
- PSMA, PET/MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 1 Dec 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.
The purpose of this study is to see if positron emission tomography/ magnetic resonance imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an investigational radioactive drug called [Ga-68]PSMA.
Detailed description
Primary Objective
The primary objective of this pilot imaging study is to determine the feasibility of using positron emission tomography/ magnetic resonance (PET/MR) with [Ga-68] prostate-specific membrane antigen (PSMA) for staging and treatment monitoring of PSMA expressing tumors. [Ga-68]PSMA PET/MR findings will be compared with standard of care imaging, patient follow up, and histopathology if available. [Ga-68]PSMA PET/MR will not be used to change the patients' treatment plan. Investigators will assess PET/MR test-retest reproducibility and compare baseline [Ga-68]PSMA PET/MR with PET/MR after initiation (within 2-6 weeks) of therapy and evaluate if [Ga-68]PSMA is a suitable biomarker for treatment monitoring and assessment of early treatment response.
Secondary Objectives
- To compare early changes in PET biomarker ([Ga-68]PSMA) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response).
- To compare changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy.
- To compare results from multi-parametric MR imaging with [Ga-68]PSMA uptake.
- To assess combinations of quantitative PET and MRI metrics.
Study Design Patients, who enroll in this study, will undergo a baseline [Ga-68]PSMA PET/MR to assess the level of [Ga-68]PSMA tumor uptake. Patients with positive [Ga-68]PSMA tumor uptake (defined as [Ga-68]PSMA uptake twice the background activity) who are receiving systemic therapy will undergo a further [Ga-68]PSMA PET/MR 2-6 weeks after start of treatment. Patients with positive [Ga-68]PSMA tumor uptake will also be offered to participate in a test- retest study with a 2nd [Ga-68]PSMA PET/MR prior to treatment. Patients will therefore undergo a maximum of three [Ga-68]PSMA PET/MR imaging procedures. The first two test-retest Ga-PSMA-PET/MRI will be performed on separate days to allow for radioactive decay. There will be no other (e.g. clinically indicated) PET scan performed on the same day of [Ga-68]PSMA-PET/MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [Ga-68]PSMA PET/MR | – | Device: [Ga-68]PSMA PET/MRUp to 3 experimental PET/MRI scans will be performed to determine the level of [Ga-68]PSMA tumor uptake |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with tumors expressing PSMA including prostate cancer, breast cancer, lung cancer, renal cancer and other tumor types [Ga-68]PSMA PET/MRI known to express PSMA
Key inclusion criteria (3 listed)
- Patients with PSMA-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express PSMA
- Patients able to tolerate PET/MRI scans
- Informed consent must be given and signed
Key exclusion criteria (8 listed)
- Subjects who do not meet the above mentioned inclusion criteria
- Subjects who refuse to give and/or sign the informed consent
- Patients who have a history of serious adverse events related to a previous MRI or PET/CT
- Patients who are unable to undergo MRI scanning due to exclusion by institutional MRI restriction policies as mentioned in the standard institutional MRI informed consent form
- Patients who are currently pregnant or breast feeding. A pregnancy test within 72 hours of the first PET/MRI will be performed.
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 |
|---|---|---|
| [Ga-68]PSMA PET/MRAlso: PET/MRIAll participants will undergo at least 1 baseline [Ga-68]PSMA PET/MR. If participants test positive for [Ga-68]PSMA tumor uptake, they will under up to 2 additional scans | Device | [Ga-68]PSMA PET/MR |
Primary outcome
Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
Time frame: Up to 6 weeks after beginning treatment
The outcome measure for the statistical analysis of the test-retest reproducibility will be concordance analysis of standard uptake values (SUVs) between the 2 baseline scans
7 secondary outcomes
Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI)
Time frame: Up to 6 weeks after beginning treatment
Ability of PET/MRI to measure changes in PET biomarker [Ga-68]PSMA) tumor uptake after initiation of therapy
Time frame: Up to 6 weeks after beginning treatment
Changes in MR signal intensities after initiation of therapy
Time frame: Up to 6 weeks after beginning treatment
Comparison of early changes in PET biomarker ([Ga68]PSMA) tumor uptake with treatment response assessed at completion of therapy
Time frame: Up to 6 weeks after beginning treatment
Comparison of changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy
Time frame: Up to 6 weeks after beginning treatment
Comparison of results from multi-parametric MR imaging with [Ga-68]PSMA tumor uptake
Time frame: Up to 6 weeks after beginning treatment
Assessment of combinations of quantitative PET and MRI metrics
Time frame: Up to 6 weeks after beginning treatment
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 7 May 2021.
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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.
Norbert Avril, MD principal investigator
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate-specific Membrane Antigen Positive Tumors and Prostate Cancer, run by Case Comprehensive 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 3 inclusion and 8 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 7 May 2021. 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?
Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI (time frame: Up to 6 weeks after beginning treatment). 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 7 May 2021.