Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03678389|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : July 12, 2021
Pituitary tumors can cause problems by secreting hormones in the body. They can also problems by growing large and pushing on organs near the pituitary gland. The best treatment for such tumors is to remove them by surgery. But that may be sometimes difficult. Some tumors maybe too small to see. Some other tumors maybe so large that portions maybe left behind during surgery. The endosphenoidal coil (ESC) is a new magnetic resonance imaging (MRI) device. It fits in a small space made during surgery near the pituitary. Researchers want to see if it helps transmit MRI signals during surgery to make better images of the pituitary gland and tumors.
To test the safety of using a new coil device to improve MRI imaging of pituitary tumors during surgery.
Adults 18-65 years old who are having pituitary tumor surgery at NIH
Participants will be screened with:
- Medical history
- Physical exam
- Review of prior brain scans
- Blood and pregnancy tests
All participants will have MRI of pituitary gland. They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will lie still and get earplugs for loud sounds. A dye will be inserted into an arm vein by needle.
Participants will stay in the hospital for about 1 week. They will repeat screening tests.
Participants will have standard pituitary surgery. They will get medicine to go to sleep. The surgeon will create a path to the pituitary gland from under the lip.
During surgery, the ESC will be placed through the path to near the pituitary. Then an MRI will be done during surgery.
Then the ESC will be removed and standard surgery will continue.
Participants will get standard post-operative care under another protocol.
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Neoplasm||Other: ESC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery|
|Actual Study Start Date :||May 9, 2019|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
USE OF ENDOSPHENOIDAL COIL (ESC) TO OBTAIN MRI IMAGING OF THE PITUITARY GLAND
- Feasibility of using ESC as a clinical tool during transsphenoidal surgery.Feasibility will be assessed by the time added to a standard TSSprocedure. [ Time Frame: 2 hours ]The primary outcome of this study is the feasibility of using ESC as a clinical tool during transsphenoidal surgery. Feasibility will be assessed by the time added to a standard TSS procedure (measured from the time the TSS exposure is completed to the time to return to the operating position for completion of surgery).
- Evaluate whether the use of ESC causes local trauma, bleeding, burns or other unanticipated safety issues during TSS. [ Time Frame: Study Completion ]Evaluate whether the use of ESC causes local trauma, bleeding, burns or other unanticipated safety issues during TSS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678389
|Contact: Gretchen C Scott, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Prashant Chittiboina, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|