Clinical trial · Observational
FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
NCT02055586CI-TRIAL-00047220completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorine F 18 fluorothymidine | Other | — | UNRESOLVED |
| magnetic resonance imaging | Device | — | UNRESOLVED |
| positron emission tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diagnostic (FLT-PET/MRI)
- description
- Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment.
- interventionNames
- Other: fluorine F 18 fluorothymidine
- Device: positron emission tomography
- Device: magnetic resonance imaging
Primary outcomes (2)
- measure
- Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans
- timeFrame
- Baseline
- description
- 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.
- measure
- Comparative Analysis of PET/MRI Images
- timeFrame
- Up to 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.