Registering Genomics and Imaging of Tumors (ReGIT)

Glioma Clinical Trial

— ReGIT  

Official title:

Registering Genomics and Imaging of Tumors (ReGIT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386043
• Other study ID #: 11163
• Status: Recruiting
• Start date: July 18, 2023
• Est. completion date: July 17, 2027

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: Jason Parker, PhD
• Phone: (317) 274-2072
• Email: parkerjg[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 17, 2027
• Est. primary completion date: July 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Subject is between 18 and 89 years of age.

2. 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*.

3. Subject is treatment-naïve for the above condition.

4. Subject is planning to undergo surgical resection and biopsy of their brain tumor.

5. Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection.

6. Subject is able to read and write in English.

7. Subject is able to lay supine for up to 80 minutes.

8. Subject is able to hold still during MRI procedures.

9. Subject or their LAR has signed the consent form for participation in the study.

Exclusion Criteria

1. Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy.

2. Subject has serious unstable medical or mental illness.

3. Subject has insufficient tissue to acquire at least two biopsy samples during resection.

4. Subject has a medical contraindication to any element of the study procedures.

5. Subject or their LAR has not read and signed the informed consent form, or does not understand its contents.

6. Subject is pregnant.**

7. Subject is at high risk for NSF (eGFR<60 or serum creatine >1.3) and cannot follow the weight-based dosing protocol for Gadavist.***

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• FET F-18
PET scan with FET prior to biopsy
• O-15 Radioisotope
PET scan with O-15 Water prior to biopsy

Procedure:
• CT scan
CT scan prior to biopsy
• MRI with gadolinium-based contrast
MRI prior to biopsy
• Biopsy Collection
Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification sensitivity	Statistical evaluation of the area under the ROC curve. 3.1.1 SMM classification sensitivity to >80% 3.1.2 Reduce computation time by a factor of 10, and maintain accuracy (>.95)	Through study completion, an average of 1 year.