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Intraoperative Imaging of Pituitary Adenomas by OTL

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ClinicalTrials.gov Identifier: NCT02629549
Recruitment Status : Active, not recruiting
First Posted : December 14, 2015
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Sunil Singhall, University of Pennsylvania

Brief Summary:
The primary end-point of the study is to determine the specificity and sensitivity of OTL38 in identifying pituitary adenomas when excited by an imaging probe. The investigators intend to enroll 50 patients in this study. The study is focusing on patients presenting with suspected pituitary adenomas who are considered to be good surgical candidates.

Condition or disease Intervention/treatment Phase
Neoplasms Pituitary Neoplasms Drug: OTL38 Phase 1

Detailed Description:

Pituitary adenomas have an estimated prevalence in the population of approximately 10%, and although they are predominantly benign tumors, they can cause significant disability from mass effect (visual field deficits and cranial nerve deficits) and from hypersecretory syndromes (Cushing's disease, acromegaly, hyperprolactinemia). Approximately 30% of all pituitary adenomas are nonfunctioning or endocrinologically silent, and despite the lack of hormonal overexpression they represent the great majority of patients of who undergo surgery given the threat of apoplexy and compression of adjacent neural structures. Surgical resection via transsphenoidal surgery remains the primary treatment modality for almost all pituitary adenomas except prolactinomas. Residual tumor, however, is quite common after surgical resection and is seen in up to 20% of surgical cases. By ensuring a negative margin through imaging during surgery, it would be possible to minimize the need for postoperative radiation therapy and/or radiosurgery and subsequent surgery as well.

Gross total resection (GTR) of a pituitary adenoma is theoretically simple but practically difficult given the intimate association of the pituitary gland with critical neurovascular structures including the internal carotid artery, optic nerves, cavernous sinus contents and adjacent frontal lobe and third ventricle. In a recent meta-analysis, functioning pituitary adenoma (Cushing's disease, prolactinoma, acromegaly) was demonstrated to have a gross total resection rate of only 78% (n=664). In another review, tabulated through multiple studies, demonstrated that for nonfunctioning pituitary adenoma, gross total resection rate ranged from 66 to 93% (n=778). Moreover, a comparison of endoscopic and microscopic removal of pituitary adenoma found the gross total resection rate was 66% using endoscopic pituitary techniques. In this context of limited ability to achieve GTR, intraoperative MRI was introduced for assessment of the degree of resection for pituitary adenoma. The intraoperative MRI is expensive, cumbersome, and impractical. A simpler means of determining the degree of resection is greatly needed in the field of brain surgery, and specifically pituitary surgery.

Pituitary adenomas are the ideal disease to investigate intra-operative imaging. Multiple studies have demonstrated that nonfunctioning pituitary adenomas express folate receptor alpha (FRα), therefore making folate receptors (FR) the ideal targets for imaging agents. While folate will initially distribute to all cells, redistribution, metabolism, and excretion will eliminate most of this agent from healthy tissues within 2-3 hours. Tumor cells that over express FRα will retain folate and any fluorescent labeled folate conjugate (such as OTL38) and internalize this.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 1, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor-alpha Positive Pituitary Adenoma
Study Start Date : October 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OTL38
Dosage calculated by weight of individual
Drug: OTL38
Infusion of OTL38 prior to surgery




Primary Outcome Measures :
  1. Detection of OTL38 in tumor tissue. [ Time Frame: 60 months ]
    The detection of OTL38 uptake by tumor tissue will be made with the use of an imaging system that detects the presence of dye in tissue.

  2. Evaluate the ability of OTL38 to discern between tumorous tissue and normal, neural tissue. [ Time Frame: 60 months ]
    Specificity and sensitivity of OTL38 will be calculated through the comparison of the video images gathered from the imaging system and the final pathology results from the surgical procedure.


Secondary Outcome Measures :
  1. Incidence rates of all adverse events, treatment-emergent adverse events and adverse device events from time of OTL38 administration through participants' first, post-operative appointment with surgeon. [ Time Frame: 60 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients over 18 years of age
  2. Patients presenting with a pituitary nodule presumed to be resectable on pre-operative assessment
  3. Good operative candidate
  4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

  1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
  2. Patients with a history of anaphylactic reactions to OTL38
  3. Patients with a known allergy to Benadryl
  4. Previous exposure to OTL38

Information from the National Library of Medicine

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): NCT02629549


Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania

Publications:

Responsible Party: Sunil Singhall, Director, Thoracic Surgery Research Laboratory, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02629549     History of Changes
Other Study ID Numbers: 822782
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Neoplasms
Pituitary Diseases
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Adenoma
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases