Head and Neck CancerPhase 2NCT05576974
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)
A Phase 2 study testing Pegsitacianine in people with Head and Neck Cancer and Unknown Primary Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Head and Neck Cancer, Unknown Primary Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Pegsitacianine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator)
- Part 1: Stage 1 to 4 HNSCC
- 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.
- 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.
- Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women <2 years after menopause)
Show all 9Show fewer
- 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
- 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.
- Adequate potential for follow up
Who cannot join
- Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible.
- Life expectancy <12 weeks
- Karnofsky Performance Status <70%
- Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis
- Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
Show all 12Show fewer
- Pregnant or lactating women
- 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
- Alcohol consumption within 72 hours before Pegsitacianine administration
- Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing
- Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study
- The PI considers that the patient should not participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
2146488096, OTOresearch@utsouthwestern.edu
2146488096, Sindhunikhila.voorugonda@utsouthwestern.edu
About this study
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Read the 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 6-300 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 6-300 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 6-300 hours, and if needed at an alternate imaging schedule post dose.
- Being tested
- Pegsitacianine
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Unknown Primary, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegsitacianineDrug
Infusion of the Pegsitacianine-Intraoperative fluorescence imaging
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Cohort A | Active comparator | In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-300 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. Receives: Drug: Pegsitacianine |
| Part 2 - Cohort B | Active comparator | In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-300 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. Receives: Drug: Pegsitacianine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC
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
Measured: 5 years
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with UPC
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
Measured: 5 years
Secondary outcomes (1)
Pegsitacianine fluorescence imaging in HNSCC, UPC primary cancers that are HPV positive and HPV negative
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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start17 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-300 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 6-300 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Baran Sumer, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576974
- Sponsor's protocol ID
- STU-2022-0460
- Other IDs
- 1R01CA266146-01
- Status last verified
- Apr 2026
- First submitted
- 5 Oct 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amit M, Yen TC, Liao CT, Chaturvedi P, Agarwal JP, Kowalski LP, Kohler HF, Ebrahimi A, Clark JR, Cernea CR, Brandao JS, Kreppel M, Zoller JE, Leider-Trejo L, Bachar G, Shpitzer T, Bolzoni AV, Patel RP, Jonnalagadda S, Robbins TK, Shah JP, Patel SG, Gil Z. The origin of regional failure in oral cavity squamous cell carcinoma with pathologically negative neck metastases. JAMA Otolaryngol Head Neck Surg. 2014 Dec;140(12):1130-7. doi: 10.1001/jamaoto.2014.1539.
PubMed 25074731Dacosta RS, Wilson BC, Marcon NE. Spectroscopy and fluorescence in esophageal diseases. Best Pract Res Clin Gastroenterol. 2006 Feb;20(1):41-57. doi: 10.1016/j.bpg.2005.08.003.
PubMed 16473800Davies B, Morris T. Physiological parameters in laboratory animals and humans. Pharm Res. 1993 Jul;10(7):1093-5. doi: 10.1023/a:1018943613122. No abstract available.
PubMed 8378254Denaro N, Russi EG, Adamo V, Merlano MC. State-of-the-art and emerging treatment options in the management of head and neck cancer: news from 2013. Oncology. 2014;86(4):212-29. doi: 10.1159/000357712. Epub 2014 May 10.
PubMed 24820548d'Alessandro AF, Pinto FR, Lin CS, Kulcsar MA, Cernea CR, Brandao LG, Matos LL. Oral cavity squamous cell carcinoma: factors related to occult lymph node metastasis. Braz J Otorhinolaryngol. 2015 May-Jun;81(3):248-54. doi: 10.1016/j.bjorl.2015.03.004. Epub 2015 Mar 30.
PubMed 25890681Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Gioux S, Choi HS, Frangioni JV. Image-guided surgery using invisible near-infrared light: fundamentals of clinical translation. Mol Imaging. 2010 Oct;9(5):237-55.
PubMed 20868625Haka AS, Volynskaya Z, Gardecki JA, Nazemi J, Lyons J, Hicks D, Fitzmaurice M, Dasari RR, Crowe JP, Feld MS. In vivo margin assessment during partial mastectomy breast surgery using raman spectroscopy. Cancer Res. 2006 Mar 15;66(6):3317-22. doi: 10.1158/0008-5472.CAN-05-2815.
PubMed 16540686Jonkman A, Kaanders JH, Terhaard CH, Hoebers FJ, van den Ende PL, Wijers OB, Verhoef LC, de Jong MA, Leemans CR, Langendijk JA. Multicenter validation of recursive partitioning analysis classification for patients with squamous cell head and neck carcinoma treated with surgery and postoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):119-25. doi: 10.1016/j.ijrobp.2006.12.002.
PubMed 17448870Kim T, Giuliano AE, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in early-stage breast carcinoma: a metaanalysis. Cancer. 2006 Jan 1;106(1):4-16. doi: 10.1002/cncr.21568.
PubMed 16329134Koller M, Qiu SQ, Linssen MD, Jansen L, Kelder W, de Vries J, Kruithof I, Zhang GJ, Robinson DJ, Nagengast WB, Jorritsma-Smit A, van der Vegt B, van Dam GM. Implementation and benchmarking of a novel analytical framework to clinically evaluate tumor-specific fluorescent tracers. Nat Commun. 2018 Sep 18;9(1):3739. doi: 10.1038/s41467-018-05727-y.
PubMed 30228269Kumar R, Roy I, Ohulchanskky TY, Vathy LA, Bergey EJ, Sajjad M, Prasad PN. In vivo biodistribution and clearance studies using multimodal organically modified silica nanoparticles. ACS Nano. 2010 Feb 23;4(2):699-708. doi: 10.1021/nn901146y.
PubMed 20088598Li Y, Zhao T, Wang C, Lin Z, Huang G, Sumer BD, Gao J. Erratum: Molecular basis of cooperativity in pH-triggered supramolecular self-assembly. Nat Commun. 2016 Dec 16;7:13777. doi: 10.1038/ncomms13777. No abstract available.
PubMed 27981971Ma X, Wang Y, Zhao T, Li Y, Su LC, Wang Z, Huang G, Sumer BD, Gao J. Ultra-pH-sensitive nanoprobe library with broad pH tunability and fluorescence emissions. J Am Chem Soc. 2014 Aug 6;136(31):11085-92. doi: 10.1021/ja5053158. Epub 2014 Jul 29.
PubMed 25020134Milenovic A, Virag M, Knezevic P, Boras VV, Ostovic KT, Panduric DG, Susic M. Evaluation of sentinel node biopsy in oral carcinomas. Coll Antropol. 2014 Mar;38(1):279-82.
PubMed 24851630
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05576974
- Acronym / sponsor ID
- STU-2022-0460
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
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 6-300 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 6-300 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 6-300 hours, and if needed at an alternate imaging schedule post dose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-300 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 6-300 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.
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Cohort A | Active comparator | Drug: PegsitacianineIn Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-300 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. |
| Part 2 - Cohort B | Active comparator | Drug: PegsitacianineIn Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-300 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults ≥18 years of age
- Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator)
- 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.
- Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women <2 years after menopause)
- 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
Key exclusion criteria (12 listed)
- Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible.
- Life expectancy <12 weeks
- Karnofsky Performance Status <70%
- Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis
- Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegsitacianineInfusion of the Pegsitacianine-Intraoperative fluorescence imaging | Drug | Part 1 - Cohort A, Part 2 - Cohort B |
Primary outcome
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
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
1 secondary outcome
Pegsitacianine fluorescence imaging in HNSCC, UPC primary cancers that are HPV positive and HPV negative
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 25074731Amit M, Yen TC, Liao CT, Chaturvedi P, Agarwal JP, Kowalski LP, Kohler HF, Ebrahimi A, Clark JR, Cernea CR, Brandao JS, Kreppel M, Zoller JE, Leider-Trejo L, Bachar G, Shpitzer T, Bolzoni AV, Patel RP, Jonnalagadda S, Robbins TK, Shah JP, Patel SG, Gil Z. The origin of regional failure in oral cavity squamous cell carcinoma with pathologically negative neck metastases. JAMA Otolaryngol Head Neck Surg. 2014 Dec;140(12):1130-7. doi: 10.1001/jamaoto.2014.1539.
- Background: PubMed 16473800Dacosta RS, Wilson BC, Marcon NE. Spectroscopy and fluorescence in esophageal diseases. Best Pract Res Clin Gastroenterol. 2006 Feb;20(1):41-57. doi: 10.1016/j.bpg.2005.08.003.
- Background: PubMed 8378254Davies B, Morris T. Physiological parameters in laboratory animals and humans. Pharm Res. 1993 Jul;10(7):1093-5. doi: 10.1023/a:1018943613122. No abstract available.
- Background: PubMed 24820548Denaro N, Russi EG, Adamo V, Merlano MC. State-of-the-art and emerging treatment options in the management of head and neck cancer: news from 2013. Oncology. 2014;86(4):212-29. doi: 10.1159/000357712. Epub 2014 May 10.
- Background: PubMed 25890681d'Alessandro AF, Pinto FR, Lin CS, Kulcsar MA, Cernea CR, Brandao LG, Matos LL. Oral cavity squamous cell carcinoma: factors related to occult lymph node metastasis. Braz J Otorhinolaryngol. 2015 May-Jun;81(3):248-54. doi: 10.1016/j.bjorl.2015.03.004. Epub 2015 Mar 30.
- Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Background: PubMed 20868625Gioux S, Choi HS, Frangioni JV. Image-guided surgery using invisible near-infrared light: fundamentals of clinical translation. Mol Imaging. 2010 Oct;9(5):237-55.
- Background: PubMed 16540686Haka AS, Volynskaya Z, Gardecki JA, Nazemi J, Lyons J, Hicks D, Fitzmaurice M, Dasari RR, Crowe JP, Feld MS. In vivo margin assessment during partial mastectomy breast surgery using raman spectroscopy. Cancer Res. 2006 Mar 15;66(6):3317-22. doi: 10.1158/0008-5472.CAN-05-2815.
- Background: PubMed 17448870Jonkman A, Kaanders JH, Terhaard CH, Hoebers FJ, van den Ende PL, Wijers OB, Verhoef LC, de Jong MA, Leemans CR, Langendijk JA. Multicenter validation of recursive partitioning analysis classification for patients with squamous cell head and neck carcinoma treated with surgery and postoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):119-25. doi: 10.1016/j.ijrobp.2006.12.002.
- Background: PubMed 16329134Kim T, Giuliano AE, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in early-stage breast carcinoma: a metaanalysis. Cancer. 2006 Jan 1;106(1):4-16. doi: 10.1002/cncr.21568.
- Background: PubMed 30228269Koller M, Qiu SQ, Linssen MD, Jansen L, Kelder W, de Vries J, Kruithof I, Zhang GJ, Robinson DJ, Nagengast WB, Jorritsma-Smit A, van der Vegt B, van Dam GM. Implementation and benchmarking of a novel analytical framework to clinically evaluate tumor-specific fluorescent tracers. Nat Commun. 2018 Sep 18;9(1):3739. doi: 10.1038/s41467-018-05727-y.
- Background: PubMed 20088598Kumar R, Roy I, Ohulchanskky TY, Vathy LA, Bergey EJ, Sajjad M, Prasad PN. In vivo biodistribution and clearance studies using multimodal organically modified silica nanoparticles. ACS Nano. 2010 Feb 23;4(2):699-708. doi: 10.1021/nn901146y.
- Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. National Cancer Institute 27NOV2017Link provided by the sponsor.
- Declaration of HelsinkiLink provided by the sponsor.
- ICH E6 (R2). Integrated addendum to ICH E6(R1): Guideline for good clinical practice. 09NOV2016Link provided by the sponsor.
- FDA Bioanalytical Method Validation Guidance for Industry, May 2018Link provided by the sponsor.
- EAFUS - Everything Added to Food in the United States. PEG: ASP, Doc#1285, CAS# 25322-68-3. Polymethacrylate: ASP, Doc# 1406, CAS# 54193-36-1Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Recurrent or Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegsitacianine in people with Head and Neck Cancer and Unknown Primary Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baran Sumer, MD (2146482904, Baran.Sumer@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576974, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.