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A Phase 1, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Pituitary Adenoma

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ClinicalTrials.gov Identifier: NCT02769533
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This study is focusing on patients presenting with suspected malignancies of the pituitary gland who are considered to be good surgical candidates.The primary end-point of the study is to determine the sensitivity of OTL38 uptake and expression in identifying those nodules when excited by an imaging probe.There will be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, two to three hours, prior to surgery.

Condition or disease Intervention/treatment Phase
Patients With Suspected Malignancies of the Pituitary Gland Drug: OTL0038 Drug: Benadryl Device: intraoperative imaging Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 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 (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Pituitary Adenoma
Study Start Date : September 2015
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : August 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pituitary adenoma
OTL38 infusion
Drug: OTL0038
Drug: Benadryl
Device: intraoperative imaging



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: five years ]
  2. Number of pituitary adenomas are detected by intraoperative imaging [ Time Frame: five years ]


Information from the National Library of Medicine

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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:

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

Exclusion Criteria:

  • Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
  • Patients with a history of anaphylactic reactions to OTL38
  • Patients with a known allergy to Benadryl
  • 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): NCT02769533


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Sunil Singhal, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02769533     History of Changes
Other Study ID Numbers: UPCC 18315
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Adenoma
Pituitary Neoplasms
Pituitary Diseases
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Diphenhydramine
Physiological Effects of Drugs
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents