Pituitary NeoplasmNCT03678389
Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
A study testing ESC in people with Pituitary Neoplasm, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pituitary Neoplasm
- What is being tested?
- ESC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2019to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (more than 18 years of age) will be included in this study if they:
- Have a known or suspected tumor of the pituitary gland that requires surgical resection through a transsphenoidal approach. There is no size restriction. Invasion of surrounding anatomical structures by the pituitary tumor will not be ground for screen failure/withdrawal from study.
- Are enrolled in 03-N-0164, Evaluation and Treatment of Neurosurgical Disorders. If not enrolled, subjects will not be able to be included in the study as clinical and research procedures are done under the 03-N-0164 protocol.
- Are able to provide written consent.
- NIH employees are included in the study.
Who cannot join
- Subjects will be excluded from this study if they:
- Are unable to fit the intra-operative MRI table due to size or weight restrictions i.e morbid obesity. Patients will be anaesthetized and therefore claustrophobia will not be ground for screen failure/withdrawal from study.
- Have an absolute contraindication to MRI imaging or MRI contrast agent according to Rad\&IS screening including devices or conditions.
- Have a variant anatomy which may, in the judgment of the operating neurosurgeon, add unacceptable risk to the placement of the endosphenoidal coil (e.g. small size of facial bones and nasal passages, unaerated sphenoid sinus etc.).
- Are pregnant or nursing.
- Patients older than 85 years of age. Cushing disease is rare in the older population.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
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.
Read more
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.
Read the 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 a 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, 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 gland provides a route for the 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 would 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. The 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 the 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. The surgeon will not view scans arising from the research procedure, and therefore intraoperative clinical decision-making will not be influenced by the results of the research imaging.
Changes in study design since inception. This trial was initiated in 2019. For the initial period, the outcome measures were listed as such:
Primary Outcome Measure: 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).
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.
By the July 2022, 10 participants had enrolled and completed the study. Based on the initial experience, the study outcomes were re-enumerated as below in December 2022. Of note, there were no changes in the objectives of the clinical trial - feasibility, safety and exploratory objectives remain unchanged. In June 2023, the upper age limit was changed to 85 years from 65 years of age.
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, the feasibility of ESC will be evaluated as follows:
- For microadenomas (pituitary adenomas smaller than 10 mm in diameter), the ability of ESC to confirm the location and size of adenomas.
- For macroadenomas (pituitary adenomas larger than 10 mm in diameter), the ability of ESC to detect invasion of the cavernous sinus and/or parasellar structures (structures surrounding the pituitary gland).
- 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.
- Pituitary SNR with ESC MRI versus pre-operative standard of care images.
- Pituitary to tumor Contrast to Noise Ratio (CNR) with ESC MRI versus pre-operative standard of care images.
- Conditions
- Pituitary Neoplasm
- Being tested
- ESC
- Keywords
- Pituitary Adenoma, pituitary surgery, Transsphenoidal Surgery, Pituitary Tumors
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESCOther
USE OF ENDOSPHENOIDAL COIL (ESC) TO OBTAIN MRI IMAGING OF THE PITUITARY GLAND
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ENDOSPHENOIDAL COIL Receives: Other: ESC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ESC as an Intraoperative Adjunct Tool
We hypothesize that using ESC is safe for patients undergoing TSS. We will monitor for adverse events that may arise due to the insertion, use and removal of the ESC. The surgical corridor will be monitored for bleeding, burns, physical trauma or impingement during insertion of ESC (by direct observation) and during imaging (via video feed), and after removal of the ESC (by direct observation). The adverse events will be graded as follows: Grade 0 uneventful deployment of the ESC; Grade I adverse events due to ESC deployment without any intra-operative consequences; Grade II adverse events due to ESC deployment needing surgical interventions (e.g. control of bleeding, modification of surgical approach, need for blood transfusion etc.) or burn injuries needing surgical management; Grade III severe adverse events due to ESC deployment needing immediate termination of the surgical procedure or permanent physical/neurologic injury due to impingement.
Measured: Ongoing
Feasibility of ESC as a Clinical Tool
Clinical utility will be evaluated by a board certified neuroradiologist. The utility measure is a binary outcome measure (yes/no). The neuroradiologist will also make additional subjective observations about the image quality, image resolution, imaging artifacts and image noise. For patients with microadenomas, the primary outcome measure will be the accuracy of the ESC in detecting previously detected microadenomas. A positive outcome measure will be denoted if a possible microadenoma is detected with the ESC in the same location as detected by pre-operative MRI imaging. For patients with pituitary macroadenomas, the primary outcome will be detection of invasion of the cavernous sinus and ability to detect intra-tumoral heterogeneity. For patients with MRI negative pituitary disease, the primary outcome measure will be the ability to detect adenomas. At the conclusion of enrollment, all images will be reviewed by an independent board-certified neuroradiologist.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start9 May 2019
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary NeoplasmStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Prashant Chittiboina, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678389
- Sponsor's protocol ID
- 180133
- Other IDs
- 18-N-0133
- Status last verified
- 20 Apr 2026
- First submitted
- 18 Sep 2018
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do plan to share IPD. We will share all IPD that results in a publication on a public repository, as required by most journals. The data will be de-identified and anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
- ClinicalTrials.gov ID
- NCT03678389
- Acronym / sponsor ID
- 180133
- Conditions
- Pituitary Neoplasm
- Keywords
- Pituitary Adenoma, pituitary surgery, Transsphenoidal Surgery, Pituitary Tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 May 2019 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 a 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, 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 gland provides a route for the 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 would 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. The 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 the 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. The surgeon will not view scans arising from the research procedure, and therefore intraoperative clinical decision-making will not be influenced by the results of the research imaging.
Changes in study design since inception. This trial was initiated in 2019. For the initial period, the outcome measures were listed as such:
Primary Outcome Measure: 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).
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.
By the July 2022, 10 participants had enrolled and completed the study. Based on the initial experience, the study outcomes were re-enumerated as below in December 2022. Of note, there were no changes in the objectives of the clinical trial - feasibility, safety and exploratory objectives remain unchanged. In June 2023, the upper age limit was changed to 85 years from 65 years of age.
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, the feasibility of ESC will be evaluated as follows:
- For microadenomas (pituitary adenomas smaller than 10 mm in diameter), the ability of ESC to confirm the location and size of adenomas.
- For macroadenomas (pituitary adenomas larger than 10 mm in diameter), the ability of ESC to detect invasion of the cavernous sinus and/or parasellar structures (structures surrounding the pituitary gland).
- 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.
- Pituitary SNR with ESC MRI versus pre-operative standard of care images.
- Pituitary to tumor Contrast to Noise Ratio (CNR) with ESC MRI versus pre-operative standard of care images.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: ESCENDOSPHENOIDAL COIL |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a known or suspected tumor of the pituitary gland that requires surgical resection through a transsphenoidal approach. There is no size restriction. Invasion of surrounding anatomical structures by the pituitary tumor will not be ground for screen failure/withdrawal from study.
- Are enrolled in 03-N-0164, Evaluation and Treatment of Neurosurgical Disorders. If not enrolled, subjects will not be able to be included in the study as clinical and research procedures are done under the 03-N-0164 protocol.
- Are able to provide written consent.
- NIH employees are included in the study.
Key exclusion criteria (6 listed)
- Are unable to fit the intra-operative MRI table due to size or weight restrictions i.e morbid obesity. Patients will be anaesthetized and therefore claustrophobia will not be ground for screen failure/withdrawal from study.
- Have an absolute contraindication to MRI imaging or MRI contrast agent according to Rad\&IS screening including devices or conditions.
- Have a variant anatomy which may, in the judgment of the operating neurosurgeon, add unacceptable risk to the placement of the endosphenoidal coil (e.g. small size of facial bones and nasal passages, unaerated sphenoid sinus etc.).
- Are pregnant or nursing.
- Patients older than 85 years of age. Cushing disease is rare in the older population.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESCUSE OF ENDOSPHENOIDAL COIL (ESC) TO OBTAIN MRI IMAGING OF THE PITUITARY GLAND | Other | 1 |
Primary outcome
Safety of ESC as an Intraoperative Adjunct Tool
Time frame: Ongoing
We hypothesize that using ESC is safe for patients undergoing TSS. We will monitor for adverse events that may arise due to the insertion, use and removal of the ESC. The surgical corridor will be monitored for bleeding, burns, physical trauma or impingement during insertion of ESC (by direct observation) and during imaging (via video feed), and after removal of the ESC (by direct observation). The adverse events will be graded as follows: Grade 0 uneventful deployment of the ESC; Grade I adverse events due to ESC deployment without any intra-operative consequences; Grade II adverse events due to ESC deployment needing surgical interventions (e.g. control of bleeding, modification of surgical approach, need for blood transfusion etc.) or burn injuries needing surgical management; Grade III severe adverse events due to ESC deployment needing immediate termination of the surgical procedure or permanent physical/neurologic injury due to impingement.
Feasibility of ESC as a Clinical Tool
Time frame: Ongoing
Clinical utility will be evaluated by a board certified neuroradiologist. The utility measure is a binary outcome measure (yes/no). The neuroradiologist will also make additional subjective observations about the image quality, image resolution, imaging artifacts and image noise. For patients with microadenomas, the primary outcome measure will be the accuracy of the ESC in detecting previously detected microadenomas. A positive outcome measure will be denoted if a possible microadenoma is detected with the ESC in the same location as detected by pre-operative MRI imaging. For patients with pituitary macroadenomas, the primary outcome will be detection of invasion of the cavernous sinus and ability to detect intra-tumoral heterogeneity. For patients with MRI negative pituitary disease, the primary outcome measure will be the ability to detect adenomas. At the conclusion of enrollment, all images will be reviewed by an independent board-certified neuroradiologist.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We do plan to share IPD. We will share all IPD that results in a publication on a public repository, as required by most journals. The data will be de-identified and anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prashant Chittiboina, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESC in people with Pituitary Neoplasm, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina P Hayes, C.R.N.P. ((301) 496-2921, christi.hayes@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ESC as an Intraoperative Adjunct Tool (time frame: Ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.