Ignite Creation Date:
2024-05-06 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03678389
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2018-09-18
Brief Title:
Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
Status:
RECRUITING
Status Verified Date:
2024-08-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
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
Objective
To test the safety of using a new coil device to improve MRI imaging of pituitary tumors during surgery
Eligibility
Adults 18-85 years old who are having pituitary tumor surgery at NIH
Design
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
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
Objective
To test the safety of using a new coil device to improve MRI imaging of pituitary tumors during surgery
Eligibility
Adults 18-85 years old who are having pituitary tumor surgery at NIH
Design
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
Detailed Description:
Tumors of the pituitary gland comprise up to 20 of all brain tumors The central location and the small size of the pituitary gland make the management of tumors particularly challenging Transsphenoidal surgery TSS to resect pituitary tumors is highly successful at achieving complete cure for functional pituitary adenomas It is most successful when such adenomas can be localized by preoperative MRI of the pituitary However in some instances small functional tumors cannot be visualized In the case of Cushing s disease CD such non-visualization may be as high as 50 The success of transsphenoidal surgery is substantially reduced in patients with negative MRI as some of the adenomas that cause CD are so small that they are difficult to find during surgical exploration of the pituitary Surgical success is also diminished when tumors invade the walls of the cavernous sinus MRI of the pituitary lacks imaging resolution to detect such invasion and so the surgeon cannot perform a complete resection with surgery based on the preoperative MRI
Signal to noise ratio SNR is the primary constraint on achieving high quality high resolution MRI images SNR can be improved by longer scan times or by increasing the field strength of the MRI magnet SNR is proportional to the square of imaging time however long imaging times are not clinically feasible SNR is linearly proportional to field strength however replacing MRI magnets is cost prohibitive
Another strong determinant of SNR is the proximity of the MRI receiver coil to the tissue being imaged Placement of a coil in close proximity to the structure of interest dramatically increases SNR often as much as 10-fold Clinically this is routinely put into practice for superficial body parts such as the temporomandibular joints in which small coils are placed directly over the joints to achieve rapid high-resolution imaging For deep structures the use of superficial coils is of no benefit This has led to the development of endocavitary coils such as the endorectal coil used to image the prostate gland Such coils are now in routine clinical use here at the NIH and elsewhere
During routine TSS the surgical approach to the pituitary provides a route for placement of imaging tools such as handheld ultrasound and Doppler probes in close proximity to the gland Extending this model to MRI imaging we realized that an endocavitary surface coil within the sphenoid sinus will allow for a marked improvement in SNR for imaging the sella To this end we have developed an endosphenoidal coil ESC demonstrated its MRI safety and performed preliminary studies in cadaver heads to determine that the ESC can be placed through the transsphenoidal approach Placement of ESC needs no modification in the surgical TSS approach to the pituitary gland The goal of this protocol is to examine the safety and feasibility of ESC placement and imaging during TSS
Objective
To evaluate the feasibility and safety of using ESC during TSS
Study Population
The study population will be up to 70 adult subjects with pituitary tumors that require TSS Enrollment will be completed once 50 subjects have received the study procedure The requested accrual ceiling of 70 subjects accounts for screening failures and drop-outs who do not receive the study procedure
Design
This is a pilot study of 50 subjects requiring TSS for pituitary lesions The subjects will undergo standard TSS resection of a pituitary adenoma in the intra-operative MR suite Following standard surgical approach the ESC will be placed into the sphenoid sinus while the bone of the sellar floor is still intact Routine clinical pituitary imaging with and without intravenous contrast will be performed for comparison with standard pituitary imaging Additional higher resolution sequences will be performed as time allows Following imaging standard surgical resection will be performed Surgeon will not view scans arising from the research procedure and therefore intraoperative clinical decisions making will not be influenced by the results of the research imaging
Outcome Measures
Primary Outcome Measure
Preliminary analysis of the data generated so far revealed that the ESC is well-designed to fit within the surgical workflow However the utility of ESC imaging was limited within the parameters of the standard sequences Depending on the specific clinical indication for TSS we found that the ESC could have differing roles as a surgical adjunct For the current amended trial feasibility of ESC will be evaluated as follows
1 For microadenomas pituitary adenomas smaller than 10 mm in diameter the ability of ESC to confirm the location and size of adenomas
2 For macroadenomas pituitary adenomas larger than 10 mm in diameter the ability of ESC to detect invasion of the cavernous sinus andor parasellar structures structures surrounding the pituitary gland
3 For MRI negative cases the ability to detect adenomas
Safety Outcome Measure
We will evaluate the safety of the ESC as a surgical adjunct tool We will evaluate whether the use of ESC causes local trauma bleeding burns or other unanticipated safety issues during TSS
Exploratory Outcome Measures
Clinical utility of these images will be evaluated by comparing SNR and contrast to noise ratio CNR measurements obtained with the ESC to preoperative standard of care images
1 Pituitary SNR with ESC MRI versus pre-operative standard of care images
2 Pituitary to tumor Contrast to Noise Ratio CNR with ESC MRI versus pre-operative standard of care images
Signal to noise ratio SNR is the primary constraint on achieving high quality high resolution MRI images SNR can be improved by longer scan times or by increasing the field strength of the MRI magnet SNR is proportional to the square of imaging time however long imaging times are not clinically feasible SNR is linearly proportional to field strength however replacing MRI magnets is cost prohibitive
Another strong determinant of SNR is the proximity of the MRI receiver coil to the tissue being imaged Placement of a coil in close proximity to the structure of interest dramatically increases SNR often as much as 10-fold Clinically this is routinely put into practice for superficial body parts such as the temporomandibular joints in which small coils are placed directly over the joints to achieve rapid high-resolution imaging For deep structures the use of superficial coils is of no benefit This has led to the development of endocavitary coils such as the endorectal coil used to image the prostate gland Such coils are now in routine clinical use here at the NIH and elsewhere
During routine TSS the surgical approach to the pituitary provides a route for placement of imaging tools such as handheld ultrasound and Doppler probes in close proximity to the gland Extending this model to MRI imaging we realized that an endocavitary surface coil within the sphenoid sinus will allow for a marked improvement in SNR for imaging the sella To this end we have developed an endosphenoidal coil ESC demonstrated its MRI safety and performed preliminary studies in cadaver heads to determine that the ESC can be placed through the transsphenoidal approach Placement of ESC needs no modification in the surgical TSS approach to the pituitary gland The goal of this protocol is to examine the safety and feasibility of ESC placement and imaging during TSS
Objective
To evaluate the feasibility and safety of using ESC during TSS
Study Population
The study population will be up to 70 adult subjects with pituitary tumors that require TSS Enrollment will be completed once 50 subjects have received the study procedure The requested accrual ceiling of 70 subjects accounts for screening failures and drop-outs who do not receive the study procedure
Design
This is a pilot study of 50 subjects requiring TSS for pituitary lesions The subjects will undergo standard TSS resection of a pituitary adenoma in the intra-operative MR suite Following standard surgical approach the ESC will be placed into the sphenoid sinus while the bone of the sellar floor is still intact Routine clinical pituitary imaging with and without intravenous contrast will be performed for comparison with standard pituitary imaging Additional higher resolution sequences will be performed as time allows Following imaging standard surgical resection will be performed Surgeon will not view scans arising from the research procedure and therefore intraoperative clinical decisions making will not be influenced by the results of the research imaging
Outcome Measures
Primary Outcome Measure
Preliminary analysis of the data generated so far revealed that the ESC is well-designed to fit within the surgical workflow However the utility of ESC imaging was limited within the parameters of the standard sequences Depending on the specific clinical indication for TSS we found that the ESC could have differing roles as a surgical adjunct For the current amended trial feasibility of ESC will be evaluated as follows
1 For microadenomas pituitary adenomas smaller than 10 mm in diameter the ability of ESC to confirm the location and size of adenomas
2 For macroadenomas pituitary adenomas larger than 10 mm in diameter the ability of ESC to detect invasion of the cavernous sinus andor parasellar structures structures surrounding the pituitary gland
3 For MRI negative cases the ability to detect adenomas
Safety Outcome Measure
We will evaluate the safety of the ESC as a surgical adjunct tool We will evaluate whether the use of ESC causes local trauma bleeding burns or other unanticipated safety issues during TSS
Exploratory Outcome Measures
Clinical utility of these images will be evaluated by comparing SNR and contrast to noise ratio CNR measurements obtained with the ESC to preoperative standard of care images
1 Pituitary SNR with ESC MRI versus pre-operative standard of care images
2 Pituitary to tumor Contrast to Noise Ratio CNR with ESC MRI versus pre-operative standard of care images
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-N-0133 | None | None | None |