RECRUITING

A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

Conditions

Head and Neck Cancer Unknown Primary Cancer Head and Neck Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.

Official Title

A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

Quick Facts

Study Start:2024-04-17

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05576974

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults ≥18 years of age 2. Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator) 1. Part 1: Stage 1 to 4 HNSCC 2. Part 2: UPC squamous cell carcinoma of the head and neck with metastatic disease to at least a single cervical node, AND no biopsy proven evidence of the primary cancer's location. 3. Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function. Elevations of creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin \>1.5× the upper limit of normal \[ULN\] must be determined to be not clinically significant by the Investigator and approved by the Medical Monitor. 4. Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women \<2 years after menopause) 5. Male patients and female patients of child-bearing potential (i.e., premenopausal women with intact reproductive organs and women \<2 years after menopause) must agree to and comply with using medically acceptable contraception including surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation), intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner's vasectomy, double-barrier method (condom or diaphragm plus spermicide or condom plus diaphragm), or abstinence during the trial and for 6 months thereafter 6. Agree to abstain from alcohol consumption from 72 hours before Pegsitacianine administration through completion of Study Day 10 (±48 hours) visit in Part 1 and Part 2. 7. Adequate potential for follow up	1. Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible. 2. Life expectancy \<12 weeks 3. Karnofsky Performance Status \<70% 4. Hepatic impairment (Child-Pugh score \>5) or significant liver disease including active hepatitis or cirrhosis 5. Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection 6. Medical or psychiatric conditions that compromise the patient's ability to give informed consent. 7. Pregnant or lactating women 8. Receiving or planned to receive, during the duration of the study, concomitant medication with a high chance of hepatotoxicity, as judged by the PI based on standard protocols within the study center 9. Alcohol consumption within 72 hours before Pegsitacianine administration 10. Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing 11. Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study 12. The PI considers that the patient should not participate in the study

Inclusion Criteria

Exclusion Criteria

1. Adults ≥18 years of age
2. Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator)
1. Part 1: Stage 1 to 4 HNSCC
2. Part 2: UPC squamous cell carcinoma of the head and neck with metastatic disease to at least a single cervical node, AND no biopsy proven evidence of the primary cancer's location.
3. Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function. Elevations of creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin \>1.5× the upper limit of normal \[ULN\] must be determined to be not clinically significant by the Investigator and approved by the Medical Monitor.
4. Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women \<2 years after menopause)
5. Male patients and female patients of child-bearing potential (i.e., premenopausal women with intact reproductive organs and women \<2 years after menopause) must agree to and comply with using medically acceptable contraception including surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation), intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner's vasectomy, double-barrier method (condom or diaphragm plus spermicide or condom plus diaphragm), or abstinence during the trial and for 6 months thereafter
6. Agree to abstain from alcohol consumption from 72 hours before Pegsitacianine administration through completion of Study Day 10 (±48 hours) visit in Part 1 and Part 2.
7. Adequate potential for follow up

1. Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible.
2. Life expectancy \<12 weeks
3. Karnofsky Performance Status \<70%
4. Hepatic impairment (Child-Pugh score \>5) or significant liver disease including active hepatitis or cirrhosis
5. Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection
6. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
7. Pregnant or lactating women
8. Receiving or planned to receive, during the duration of the study, concomitant medication with a high chance of hepatotoxicity, as judged by the PI based on standard protocols within the study center
9. Alcohol consumption within 72 hours before Pegsitacianine administration
10. Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing
11. Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study
12. The PI considers that the patient should not participate in the study

Contacts and Locations

Study Contact

Baran Sumer, MD

CONTACT

2146482904

Baran.Sumer@UTSouthwestern.edu

Sindhu Voorugonda, MBBS

CONTACT

2146488096

Sindhunikhila.voorugonda@utsouthwestern.edu

Study Locations (Sites)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-17

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-04-17

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Cancer
Unknown Primary Cancer
Head and Neck Squamous Cell Carcinoma