Clinical trial · Interventional
IMAGE Study: Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
IMAGE Study: Individualized Molecular Analyses Guide Efforts in Breast Cancer - Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
- 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 study will test the feasibility of identifying patients who could benefit from tumor molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of the identification of possible actionable mutations that are not just biologically interesting but are clinically relevant. The investigators will also examine the outcome data from patients who followed the Molecular Profiling Tumor Board suggestion compared with those who did not. When the tissue studies are done, an additional group of patients will be enrolled to test if the same is possible in blood samples.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment suggestion | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Molecular prolfiling in tissue
- description
- Participant's tumor will be analyzed by Foundation Medicine on their FoundationOne platform - a targeted whole exome sequencing of 182 cancer related genes (3,230 exons) as well as 37 introns from 14 genes commonly rearranged or altered in cancer via next-generation sequencing technology to provide a molecular profile for a possible treatment suggestion
- interventionNames
- Other: Treatment suggestion
- type
- NO_INTERVENTION
- label
- Molecular prolfiling in blood
- description
- Participant's blood sample will be analyzed by Foundation Medicine on their FoundationOne platform - a targeted whole exome sequencing of 182 cancer related genes (3,230 exons) as well as 37 introns from 14 genes commonly rearranged or altered in cancer via next-generation sequencing technology; however, this is just being done to see if it is possible to generate similar results in blood samples. We do not yet know if blood sample results may be used for treatment decision (this will be tested in a future study) and results will not be given to participants; therefore, no treatment suggestion will be given.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
MOLECULAR PROFILING IN TISSUE: Inclusion Criteria: * Male or Female * 18 years of age or older * Metastatic breast cancer and treatment with prior chemotherapy (either in adjuvant, neoadjuvant or metastatic setting) * Triple negative clinical phenotype (ER-, PR-, HER2-). For HER2 assessment, a negative result is an immunohistochemical (IHC staining of 0 or 1+, a FISH result of less than 4.0 HER2 gene copies per nucleus, or a FISH ratio of less than 1.8. ER/PR will be assessed by IHC and will be defined as positive/negative using the American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) Guidelines. Estrogen receptor (ER) and progesterone receptor (PR) assays will be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. NOTE: A triple negative clinical phenotype based upon the patient's clinical course may also be eligible as determined at the discretion of the Study Chair (ie, if a patient is behaving clinically as ER/PR negative but does not meet the strict criteria outlined.) * Patients must have a tumor suitable for biopsy and be deemed medically appropriate to undergo a biopsy * Able to voluntarily provide informed consent Exclusion Criteria: * N/A MOLECULAR PROFILING IN BLOOD: Inclusion Criteria: * Male or Female * 18 years of age or older * Metastatic breast cancer * Any phenotype of breast cancer is eligible for enrollment (i.e., any ER, PR, and HER2 status). * Able to voluntarily provide informed consent Exclusion Criteria: * N/A
References
Publications (0)
Data not yet available