ClinicalTrials.gg
Not yet recruitingNCT07919509Updated Nov 5, 2026

A Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures

A Phase 1 interventional study of Panitumumab-IRDye800 in Cancer, Chemotherapy and Squamous Cell Carcinoma (SCC), sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Primary conditionCarcinoma, Squamous CellRegistry: NeoplasmsReclassifiedWhy we changed it
Registry
Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma, Squamous Cell
Why
  1. The study's listed conditions name Carcinoma, Squamous Cell, a narrower term within Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Alabama at Birmingham · Phase 1, Interventional, and Diagnostic

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 328 studies in Carcinoma, Squamous Cell with a site in United States — 66 open to participants now, 97 under way, 6 of them phase 3. Carcinoma, Squamous Cell · United States.

Planned enrollment
242nd of 278
6 · median 37
Started
2026
with 25 others
Phase 1
80 of 328
19 open now
Primary completion
2027-11
later than 54 of 96 live
Registered
328th of 328
by date

Among the 328 studies in Carcinoma, Squamous Cell with a site in United States, this one is the 242nd largest by planned enrollment of the 278 interventional ones that give a count, is one of 26 that started in 2026, is one of 80 in phase 1, reaches primary completion later than 54 of the 96 other live ones, and was the 328th registered.

Carcinoma, Squamous Cell

627 studies on the registry are indexed under Carcinoma, Squamous Cell; 133 are open to participants now.

Browse Carcinoma, Squamous Cell studies →

Open to participants now

66 of the 328 studies in Carcinoma, Squamous Cell with a site in United States are open now. Recruiting first, the newest first:

61 more — sign in →

All 66 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 100 Carcinoma, Squamous Cell studies recruiting now, 84 (84%) set no upper age limit and 8 (8%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 328 studies in Carcinoma, Squamous Cell with a site in United States, or all of them as a file.
02

Study summary

This is a pilot project to determine the safety and feasibility of using panitumumab-IRDye800 to detect cancerous tissue compared to normal surrounding tissue in participants with ovarian cancer undergoing surgical resection. This study is an extension of the work previously done using this agent in patients with squamous cell carcinoma (SCC) of the head and neck, exploring its utility in a different cancer type.

Read the detailed description

The study is an open label, single site, Phase I study to determine the safety and feasibility of using conjugated panitumumab-IRDye800 in patients with ovarian cancer undergoing surgical resection. Tumor to background ratios (TBRs) will be determined by comparing fluorescence intensity of tumor tissue to grossly normal tissue in the field. The presence of tumor tissue and fluorescence will be confirmed by histopathologic analysis.

Panitumumab-IRDye800CW has a toxicity and pharmacodynamic profile that matches the parent compound. In this study, patients will receive a 50mg flat dose of panitumumab-IRdye800 without a loading dose of panitumumab alone, which was found in the Phase I study of patient with head and neck cancer to be the safest and most cost-effective dose in a dose-range escalation study with high sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) for fluorescence detection of tumor compared to normal background tissue. This infusion will occur 24-72 hours prior to planned surgery.

03

Conditions studied

  • Cancer
  • Chemotherapy
  • Squamous Cell Carcinoma (SCC)

Browse trials for

Keywords

  • Cancer
  • Chemotherapy
  • squamous cell carcinoma (SCC)
04

In context

Carcinoma, Squamous Cell Reclassified

627 studies on the registry are indexed under Carcinoma, Squamous Cell; 133 are open to participants now.

This study's planned enrollment of 6 is below the median of 45 across 476 interventional studies indexed under Carcinoma, Squamous Cell.

Browse Carcinoma, Squamous Cell studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Compared within Carcinoma, Squamous Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. -confirmed diagnosis of ovarian cancer.
  2. Diagnosis of any stage.
  3. Diagnosis of any histology.
  4. Planning to undergo surgical resection via any modality (i.e., open, laparoscopic, robotic) with primary cytoreduction or interval debulking following chemotherapy.
  5. Age ≥ 18 years
  6. 1
  7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:

    1. ≥ 9 gm/dL
    2. ≥ 1500
    3. White Blood Cell count > 3000/mm3
    4. count ≥ 100,000/mm3
    5. Serum creatinine ≤ 1.5 times upper reference range

Exclusion criteria

Exclusion Criteria:

  1. Received an drug within 30 days prior to first dose of panitumumab-IRDye800
  2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
  3. History of infusion reactions to any monoclonal antibody therapies
  4. Pregnant or breast-feeding
  5. Evidence of on pretreatment (greater than 440 ms in males or greater than 450 ms in females)
  6. Magnesium or potassium lower than the normal institutional values
  7. Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  9. TSH > 13 micro International Units/mL
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

06

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Patients requiring surgical resection of ovarian cancer

    Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity.

    Drug: Panitumumab-IRDye800

Interventions

  • DrugPanitumumab-IRDye800

    Drug pages: Panitumumab · IRDye800

    Single IV systemic infusion of panitumumab-IRDye800 and NIR imaging of cancer during and after surgical resection. Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. All appropriate labs, tests, and safety monitoring will occur as outlined in Section 8.1. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity.

07

What researchers measure

Primary outcomes

  1. Number of Dose limiting toxicity (DLT)

    Dose limiting toxicity (DLT) defined as any grade 2 or greater toxicity that is considered definitely related to the study drug, considered clinically significant by the Principal Investigator, and occurs within 15 days of receiving treatment.

    Time frame: up to 15 days after infusion

08

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
    • Michelle Osoinak, BSN, RN, CNOR · Contactmosoinak@uabmc.edu · 205-539-2903
    • Teresa Boitano, MD · Principal investigator
    • Jason Warram, PhD · Sub investigator
09

References and documents

Publications

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Individual participant data

Plan to share: No

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

Of 42 phase 1 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 62. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2026
First posted
Nov 5, 2026
StartEst.
Nov 2026
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07919509
Responsible party
Teresa Boitano (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Nov 5, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Michelle Osoinak, BSN, RN, CNOR
Contact
mosoinak@uabmc.edu
205-539-2903
Teresa Boitano, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Panitumumab · IRDye800

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