This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 15 for:    sumer
Previous Study | Return to List | Next Study

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05576974
Recruitment Status : Not yet recruiting
First Posted : October 13, 2022
Last Update Posted : October 17, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Baran Sumer, University of Texas Southwestern Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Unknown Primary Cancer Head and Neck Squamous Cell Carcinoma Drug: Pegsitacianine Phase 2

Detailed Description:

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

The main purpose of this study is to investigate whether Pegsitacianine can be used to image head and neck cancers as well as unknown primary cancer of the head and neck 6-100 hours post dose in patients undergoing routine surgery for biopsy, evaluation, detection or removal of their primary cancer.

The study consists of two Parts.

  • Part 1 will be performed in a single dose of 1 mg/kg given such that Pegsitacianine fluorescence can be used to image primary tumors in patients with HNSCC undergoing routine surgery at 6-100 hours, and if needed at an alternate imaging schedule post dose.
  • Part 2 will be performed in a single dose of 1 mg/kg given such that Pegsitacianine fluorescence can be used to image primary tumors in patients with unknown primary cancer of the head and neck (UPC) at 6-100 hours, and if needed at an alternate imaging schedule post dose.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-100 hours prior to surgery will be used to image primary tumors in patients with HNSCC to evaluated to verify the diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes.

In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-100 hours prior to surgery will be used to in patients with unknown primary cancer of the head and neck. These patients typically undergo exam under anesthesia with a laryngoscopy as well as panendoscopy for identifying the source of the metastatic cancer found in the cervical nodes. Subjects for Part 2 may begin dosing at any time during Part 1 thus the two parts can run concurrently.
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Diagnostic
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)
Estimated Study Start Date : July 1, 2024
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Part 1 - Cohort A
In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-100 hours prior to surgery will be used to image primary tumors in patients with HNSCC to evaluated to verify the diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes.
 Drug: Pegsitacianine
Infusion of the Pegsitacianine-Intraoperative fluorescence imaging
Active Comparator: Part 2 - Cohort B
In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-100 hours prior to surgery will be used to in patients with unknown primary cancer of the head and neck. These patients typically undergo exam under anesthesia with a laryngoscopy as well as panendoscopy for identifying the source of the metastatic cancer found in the cervical nodes. The diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes in these patients will be evaluated. All the available data to date will be used to decide the additional tumor type(s), number of patients per tumor type, and number of Group(s) to be enrolled.
 Drug: Pegsitacianine
Infusion of the Pegsitacianine-Intraoperative fluorescence imaging


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC [ Time Frame: 5 years ]
    Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours) post dose. All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±24 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs

  2. Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with UPC [ Time Frame: 5 years ]
    Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours). All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±48 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs


Secondary Outcome Measures :
  1. Pegsitacianine fluorescence imaging in HNSCC, UPC primary cancers that are HPV positive and HPV negative [ Time Frame: 5 years ]
    Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Assessment of use of Pegsitacianine for intra-operative imaging of HNSCC, UPC and metastatic lymph nodes will include quantification of intraoperative and postoperative fluorescence signals from histology confirmed tumor and normal tissues, calculation of TBR and diagnostic performance. Feasibility determination will be based on a combined assessment of intraoperative in vivo and ex vivo fluorescent signals together with ex vivo examinations (histological examination, NIR flatbed scanning).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05576974


Contacts
Layout table for location contacts
Contact: Baran Sumer, MD 2146482904 Baran.Sumer@UTSouthwestern.edu
Contact: Asha Varghese, MS 2146488096 Asha.Varghese@utsouthwestern.edu

Locations
Layout table for location information
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Contact    214-648-8096    OTOresearch@utsouthwestern.edu   
Contact    2146488096    Asha.Varghese@utsouthwestern.edu   
Principal Investigator: Baran Sumer, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Cancer Institute (NCI)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Baran Sumer, Professor and Chief, Division of Head and Neck Oncology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05576974    
Other Study ID Numbers: STU-2022-0460
1R01CA266146-01 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: October 17, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Unknown Primary
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes