Registering Genomics and Imaging of Tumors
J
Jason Parker
Primary Investigator
Enrolling By Invitation
18-89 years
All
Phase
N/A
10 participants needed
3 Locations
Brief description of study
What is the purpose of this study?
This research is being done to see if genetic mutations inside brain tumors can be identified using pictures from MRI or PET scanners, instead of using needles or surgery. To conduct the study, we need to take pictures of the locations of tumor samples as they are removed during surgery. The samples then get studied for genetic mutations, and we look at the parts of the image the samples came from to see if they could have been predicted.
Our subject population will consist of a single-arm of human glioma patients (WHO grade II-IV) in an age range of 18-89 years. Patients will be recruited from the IU Health system of academic hospitals including Simon Cancer Center (an NCI-designated Comprehensive Cancer Center), Methodist Hospital, University Hospital, Neuroscience Center, North Hospital, and Saxony Hospital. The total recruitment target for this protocol is up to 20 glioma patients, or approximately 10 patients per year.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.
- Subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study.
- Subjects will complete two visits and will then undergo a follow-up period.
- At the baseline visit, subjects will under go a pregnancy test (if applicable), two PET-CT scans using different radioactive tracers, an MRI scan, and blood draws.
- At the biopsy visit, the subject will undergo an MRI scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy.
- The study team will take pictures of the locations of tumor samples as they are removed during surgery.
- The samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted.
- Follow-up MRIs and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician.
- The study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Glioma
-
Age: Between 18 Years - 89 Years
-
Gender: All
Inclusion Criteria
- Subject is between 18 and 89 years of age.
- Subject has radiologically-diagnosed or suspected WHO Grade II-IV glioma based on physician review or conformance with published WHO criteria as evaluated by the PI*.
- Subject is treatment-naïve for the above condition.
- Subject is planning to undergo surgical resection and biopsy of their brain tumor.
- Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection.
- Subject is able to read and write in English.
- Subject is able to lay supine for up to 80 minutes.
- Subject is able to hold still during MRI procedures.
- Subject or their LAR has signed the consent form for participation in the study.
Exclusion Criteria
- Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy.
- Subject has serious unstable medical or mental illness.
- Subject has insufficient tissue to acquire at least two biopsy samples during resection.
- Subject has a medical contraindication to any element of the study procedures.
- Subject or their LAR has not read and signed the informed consent form, or does not understand its contents.
- Subject is pregnant.**
- Subject is at high risk for NSF (eGFR<60 or serum creatine >1.3) and cannot follow the weight-based dosing protocol for Gadavist.***
Updated on
28 Sep 2024.
Study ID: 11163, RADY-IIR-REGIT
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