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

Trial Summary

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.

How does the Endosphenoidal Coil Placement treatment for pituitary tumors differ from other treatments?

Endosphenoidal Coil Placement is unique because it involves placing coils directly into the blood vessels near the pituitary tumor, which is different from traditional surgical or radiation treatments. This method is similar to endovascular coiling used for aneurysms, where coils are inserted to block blood flow to the target area, potentially reducing the tumor's blood supply and size. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Prashant Chittiboina, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Endovascular treatment of a complex bilobed left superior hypophyseal internal carotid artery aneurysm: a case illustration. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Transarterial embolization of cerebrospinal lesions with liquid coils. [2017]

4. United States 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. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Navigation of Stents across Communicating Arteries for Aneurysm Embolization. [2019]