Clinical trial · Interventional
An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer
NCT02380209CI-TRIAL-00024479terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI has terminated study as the sequencing on patients and volunteers didn't yield the results expected. PI has no plans for scholarly/scientific presentations.
Summary
Brief summary (as posted)
Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CEST MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Optimization
- description
- CEST MRI of the breast for estimation of tumor pH.
- interventionNames
- Other: CEST MRI
Primary outcomes (1)
- measure
- pH measurement of the tumor will be measured by the CEST MRI.
- timeFrame
- 2 weeks
- description
- pH estimate of the tumor
Secondary outcomes (1)
- measure
- Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.
- timeFrame
- 2 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast * \>= 1.0 cm primary tumor * Calculated creatinine clearance \>= 50 mL/min * Willing and able to provide informed consent * Age ≥ 18 years * ECOG performance status 0-2 * Informed of the investigational nature of this study Exclusion Criteria: * Allergy to iodinated contrast agent * Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs * Diabetes mellitus * History of severe claustrophobia * Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI * Use of \> 1 antihypertensive drug * Pregnancy or breastfeeding * Paraproteinemia syndromes or multiple myeloma * Collagen vascular disease * Active hyperthyroidism * Active pharmaceutical treatments for cancer
References
Publications (0)
Data not yet available
No reference posted for this study.