A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    48
  • sponsor
    Alume Biosciences, Inc.
Updated on 4 February 2021
serum pregnancy test
neck surgery
hormonal birth control
thyroidectomy
neck dissection
parotidectomy

Summary

Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head & neck surgery.

Description

This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head & neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics.

Details
Condition Surgery, Thyroid Adenoma, Surgical aspects, Surgery, head and neck cancer, Diagnostic Imaging, Thyroid disorder, Malignant neoplasm of parotid gland, Nerve Injury, Thyroid Disease, Thyroid Disorders, Thyroid Cancer, head and neck neoplasms, head and neck tumor, nerve damage, neural injury, nerve injuries, medical imaging, imaging procedure, imaging techniques, imaging procedures, surgical procedures, surgical treatment, surgeries, surgical procedure
Treatment ALM-488
Clinical Study IdentifierNCT04420689
SponsorAlume Biosciences, Inc.
Last Modified on4 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Thyroid Adenoma or Surgery or Surgical aspects or Thyroid Cancer or Thyroid disorder or Thyroid Disorders or Diagnostic Imaging or head and neck cance...?
Do you have any of these conditions: surgeries or Thyroid Disorders or surgical procedure or medical imaging or head and neck neoplasms or nerve damage or imaging procedures or nerve inju...?
Do you have any of these conditions: Thyroid Cancer or surgical procedure or head and neck tumor or Thyroid Disease or Thyroid disorder or Diagnostic Imaging or Surgical aspects or surgic...?
A neoplasm located in the head and neck
Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection
Can understand and is willing to sign a written informed consent document
18 years of age
Life expectancy of at least 6 months
Normal liver and kidney functions
If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence
Plans to undergo head and neck surgery

Exclusion Criteria

Prior radiation or chemotherapy for any prior head and neck neoplasm
Open surgery in the ipsilateral head and neck within 1 year
Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year
Current evidence of renal disease
Pregnant or breastfeeding
Unresolved acute toxicity from prior anti-cancer therapy
History of fluorescein allergy
Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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