Endosphenoidal Coil Placement for Pituitary Tumors

Overseen By Prashant Chittiboina, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Disqualifiers: Morbid obesity, MRI contraindications, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the endosphenoidal coil, which enhances MRI images of pituitary tumors during surgery. Pituitary tumors can disrupt hormone levels or grow large enough to press on nearby organs, causing health issues. The device provides surgeons with clearer images of the tumors, making surgery more precise. Adults scheduled for pituitary tumor surgery who can undergo MRI scans are suitable candidates for this study. As an unphased trial, it offers patients the chance to contribute to advancements in surgical imaging technology.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the endosphenoidal coil is safe for use in pituitary tumor surgeries?

Research has shown that the endosphenoidal coil (ESC) is safe for use in medical settings. Early studies indicate that the coil significantly enhances MRI image clarity, aiding doctors in obtaining better views of the pituitary gland during surgery. Initial tests, including those on human bodies donated for research, confirmed the coil's safety in MRI machines.

Although information about its use in living people is limited, similar devices have been used safely in other medical procedures. This suggests that the ESC can likely be used without causing harm. However, as this trial is in its early stages, further research is necessary to fully understand its safety in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for pituitary tumors involve surgery or radiation to remove or shrink the tumor. However, the endosphenoidal coil offers a unique approach by using a minimally invasive delivery method directly to the tumor site. This coil can be precisely placed to target the tumor without affecting surrounding tissues, potentially reducing recovery time and minimizing side effects compared to traditional surgical methods. Researchers are excited about this technique because it could offer a more targeted, less invasive option for patients, which might improve outcomes and quality of life during treatment.

What evidence suggests that the endosphenoidal coil is effective for improving MRI imaging of pituitary tumors?

Research has shown that using a special tool called the endosphenoidal coil (ESC), which participants in this trial will receive, can improve MRI scans of pituitary tumors. The ESC creates clearer images, aiding surgeons in seeing and removing these tumors. Studies have found that surgery through the nose to remove pituitary tumors often succeeds. Advanced imaging with the ESC can enhance these surgeries by reducing surgery time and blood loss. By providing better images, the ESC helps surgeons perform more precise and effective surgeries on pituitary tumors. ^{4 6 7 8 9}

Who Is on the Research Team?

Prashant Chittiboina, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Are You a Good Fit for This Trial?

Adults aged 18-85 scheduled for pituitary tumor surgery at NIH can join. They must be able to consent and fit on the MRI table, without contraindications to MRI or its contrast agent. Pregnant or nursing individuals, those with variant anatomy posing risks, or over 85 are excluded.

Inclusion Criteria

I am an adult with a pituitary gland tumor needing surgery.

NIH employees are included in the study

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.

Exclusion Criteria

Are pregnant or nursing

You are too big or heavy to fit on the MRI table during surgery. Being scared of tight spaces is not a reason to be excluded from the study.

Have an absolute contraindication to MRI imaging or MRI contrast agent according to Rad&IS screening including devices or conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo standard transsphenoidal surgery with the placement of the endosphenoidal coil for MRI imaging during surgery

1 week

In-hospital stay

Follow-up

Participants receive standard post-operative care and are monitored for safety and effectiveness of the procedure

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Endosphenoidal Coil

Trial Overview The trial is testing a new device called an endosphenoidal coil (ESC) during transsphenoidal surgery. The ESC aims to improve MRI images of the pituitary gland and tumors in real-time during the operation.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

ENDOSPHENOIDAL COIL

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

In a study involving 20 patients, endovascular embolization using liquid coils was performed successfully in 22 procedures, achieving complete obliteration of target vessels without any complications.

Liquid coils proved to be a safe and effective embolic material, facilitating subsequent surgical resections of embolized lesions in 14 cases and radiosurgery in 2 cases, although some large vessels required additional embolic materials for complete occlusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transarterial embolization of cerebrospinal lesions with liquid coils. Hara, Y., Nakamura, M., Ehara, K., et al.[2017]

In a study of 8 patients with aneurysms, crossing the Circle of Willis to assist in stent deployment resulted in satisfactory obliteration of the aneurysms, demonstrating the technique's efficacy despite its technical challenges.

While the procedure was successful, there were two cases of minor subarachnoid hemorrhage (SAH) post-operation, highlighting the need to weigh the risks against the benefits when using this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation of Stents across Communicating Arteries for Aneurysm Embolization. Ahmed, ME., Lum, C., Lesiuk, H., et al.[2019]

The dual microcatheter technique was successfully used to treat 85 small aneurysms with complex geometries, demonstrating safety with no significant differences in complications between very small (≤3 mm) and small (3-7 mm) aneurysms.

Patients with very small aneurysms showed better outcomes, with lower recanalization rates and higher packing density, indicating that this technique is particularly effective for challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double microcatheter technique for coil embolization of small aneurysms with unfavorable configurations: A comparative study of the aneurysms that are ≤3 mm or >3 mm. Yin, L., Wei, M., Ren, H.[2018]

A 62-year-old female underwent a successful stent-assisted coiling procedure for an 11-mm complex aneurysm without any complications, indicating the safety of this intervention.

The procedure involved careful coiling of both lobes of the aneurysm, with follow-up planned to assess any residual filling, demonstrating the efficacy of the technique in managing complex aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of a complex bilobed left superior hypophyseal internal carotid artery aneurysm: a case illustration. Hamade, YJ., El Tecle, NE., Zammar, SG., et al.[2014]

The EDC-10 infini coil demonstrated excellent conformability and safety in embolizing cavernous sinus dural arteriovenous fistulas (DAVFs) in six patients, with no cases of permanent cranial nerve palsy reported.

While two patients experienced transient abducens palsy post-operation, they both fully recovered, indicating that the EDC-10 infini coil is a safe option for this complex procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a unique straight, conformable, bare platinum coil in the treatment of cavernous sinus dural arteriovenous fistula. Harada, K., Kakumoto, K.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12255173/

Assessing surgical outcomes in pituitary adenoma The operative time and blood loss were significantly lower in MTS (254.22 ± 37.65 vs. 289.53 ± 23.98) with p values of 0.0164 and 0.0001, ...

2. clinicaltrial.be clinicaltrial.be/en/details/134620?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Feasibility of Endosphenoidal Coil Placement for Imaging... Transsphenoidal surgery (TSS) to resect pituitary tumors is highly successful at achieving a complete cure for functional pituitary adenomas.

3. withpower.com withpower.com/trial/phase-pituitary-diseases-4-2019-44ca8

Endosphenoidal Coil Placement for Pituitary Tumors ... Endosphenoidal Coil will have tolerable side effects & efficacy for patients with Pituitary Tumors and Pituitary Tumors. See if you qualify today!

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11107335/

Radiographic and clinical outcomes using intraoperative ... General hormone remission rates have been reported at approximately 62.5% even with use of the endoscope and iMRI, but vary based on hormone ...

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2022.837025/full

Outcome of Endoscopic Transsphenoidal Surgery for ... Endocrinological remission was achieved in 8 cases, including 1, 5, and 2 with prolactinoma, GH-secreting adenomas, and ACTH-secreting adenomas, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03678389

Feasibility of Endosphenoidal Coil Placement for Imaging ... To this end, we have developed an endosphenoidal coil (ESC), demonstrated its MRI safety, and performed preliminary studies in cadaver heads to determine that ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5093080/

Endosphenoidal coil for intraoperative magnetic resonance ... We have found that ESC resulted in an approximately 10-fold improvement in SNR in the sella/pituitary gland.

8. thejns.org thejns.org/view/journals/j-neurosurg/140/5/article-p1262.xml

Flexible in-cavity MRI receiving coil for ultra–high-resolution ... Overall, these data demonstrate that the flexible transnasal coil can likely be safely used in a clinical setting and has the potential to ...

9. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1702521?innerWidth=412&offsetWidth=412&device=desktop&id=&lang=en

First-in-Human Intraoperative MRI Coil for High ... - Thieme Connect In modern series, failure rates following TSS range from 20 to 80% with recurrences in up to 7 to 35% cases. Surgical failures and recurrences are particularly ...