Unspecified Adult Solid Tumor, Protocol SpecificNCT02055586
FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
An observational study of Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- fluorine F 18 fluorothymidine, positron emission tomography and magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2013to 27 Dec 2017
- 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 with metastatic solid tumors scheduled to undergo treatment with novel cancer therapeutic agents as SOC treatment at a cancer center hospital
Who may be able to join
- Patients with metastatic solid tumors scheduled to undergo treatment with novel cancer therapeutic agents as standard of care (SOC) treatment.
- 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 currently have a pacemaker
- 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 UHCMC MRI restriction policies as mentioned in the standard UHCMC MRI informed consent form
- Patients with a known allergy against any component of the contrast enhancing agent
Show all 9Show fewer
- Patients who currently pregnant or breast feeding; negative serum pregnancy test within 72 hours of their first FLT-PET/MRI
- Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 4 weeks
- Renal insufficiency: elevated creatinine and/or glomerular filtration rate (GFR) < 40 ml/min/1.73^2 (exclusion criterion only for contrast enhanced MRI)
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Diagnostic procedures, such as FLT-PET/MRI, may help measure a patient's response earlier during treatment.
Read the detailed description
PRIMARY OBJECTIVES:
The primary objective of this pilot imaging study is to determine the feasibility of FLTPET/MR imaging for early prediction of treatment response in patients undergoing antiangiogenic cancer treatment. The study will assess PET/MRI test-retest reproducibility and compare baseline PET/MRI with PET/MRI after initiation (within 2-4 weeks) of antiangiogenic therapy.
SECONDARY OBJECTIVES:
- To compare early changes in PET biomarker (FLT) 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 FLT tumor uptake.
- To assess combinations of quantitative PET and MRI metrics.
OUTLINE:
Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment.
- Being tested
- fluorine F 18 fluorothymidine, positron emission tomography, magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorine F 18 fluorothymidineOther
Also called 18F-FLT, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F-18
Undergo FLT-PET/MRI
positron emission tomographyDevice
Also called PET/MR, PET, PET scan, tomography, emission computed
Undergo FLT-PET/MRI
magnetic resonance imagingDevice
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo FLT-PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (FLT-PET/MRI) | Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment. Receives: Other: fluorine F 18 fluorothymidine; Device: positron emission tomography; Device: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans
A sample size of 20 produces a two-sided 95% confidence interval [0.553, 0.918] for the Pearson correlation coefficient when the sample correlation is 0.80. Additional analysis for concordance will include Bland-Altman plots and intraclass correlation.
Measured: Baseline
Comparative Analysis of PET/MRI Images
Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start22 Oct 2013
- Primary completion27 Nov 2017
- Study completion27 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Avril, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055586
- Sponsor's protocol ID
- CASE3Y12
- Other IDs
- NCI-2013-01177
- Status last verified
- Sep 2020
- First submitted
- 3 Feb 2014
- Last updated
- 18 Sep 2020
- 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 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
- ClinicalTrials.gov ID
- NCT02055586
- Acronym / sponsor ID
- CASE3Y12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 22 Oct 2013 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 5 Feb 2014 (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.
This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Diagnostic procedures, such as FLT-PET/MRI, may help measure a patient's response earlier during treatment.
Detailed description
PRIMARY OBJECTIVES:
The primary objective of this pilot imaging study is to determine the feasibility of FLTPET/MR imaging for early prediction of treatment response in patients undergoing antiangiogenic cancer treatment. The study will assess PET/MRI test-retest reproducibility and compare baseline PET/MRI with PET/MRI after initiation (within 2-4 weeks) of antiangiogenic therapy.
SECONDARY OBJECTIVES:
- To compare early changes in PET biomarker (FLT) 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 FLT tumor uptake.
- To assess combinations of quantitative PET and MRI metrics.
OUTLINE:
Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (FLT-PET/MRI) | – | Other: fluorine F 18 fluorothymidine, Device: positron emission tomography, Device: magnetic resonance imagingPatients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic solid tumors scheduled to undergo treatment with novel cancer therapeutic agents as SOC treatment at a cancer center hospital
Key inclusion criteria (3 listed)
- Patients with metastatic solid tumors scheduled to undergo treatment with novel cancer therapeutic agents as standard of care (SOC) treatment.
- Patients able to tolerate PET/MRI scans
- Informed consent must be given and signed
Key exclusion criteria (9 listed)
- Subjects who do not meet the above mentioned inclusion criteria
- Subjects who refuse to give and/or sign the informed consent
- Patients who currently have a pacemaker
- 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 UHCMC MRI restriction policies as mentioned in the standard UHCMC MRI informed consent form
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 |
|---|---|---|
| fluorine F 18 fluorothymidineAlso: 18F-FLT, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F-18Undergo FLT-PET/MRI | Other | Diagnostic (FLT-PET/MRI) |
| positron emission tomographyAlso: PET/MR, PET, PET scan, tomography, emission computedUndergo FLT-PET/MRI | Device | Diagnostic (FLT-PET/MRI) |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo FLT-PET/MRI | Device | Diagnostic (FLT-PET/MRI) |
Primary outcome
Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans
Time frame: Baseline
A sample size of 20 produces a two-sided 95% confidence interval [0.553, 0.918] for the Pearson correlation coefficient when the sample correlation is 0.80. Additional analysis for concordance will include Bland-Altman plots and intraclass correlation.
Comparative Analysis of PET/MRI Images
Time frame: Up to 4 weeks
Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy
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 18 Sep 2020.
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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 principal investigator
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 Unspecified Adult Solid Tumor, Protocol Specific, 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 9 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 18 Sep 2020. 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?
Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans (time frame: Baseline). 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 18 Sep 2020.