Gastrointestinal CancerEarly Phase 1NCT06511037
PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis
A Early Phase 1 study testing Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging in people with Gastrointestinal Cancer and Peritoneal Carcinomatosis, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Peritoneal Carcinomatosis
- What is being tested?
- Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 30 Nov 2027
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years of age and older
- Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery
- Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery
- Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion
- Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by study restrictions
Who cannot join
- Previous exposure to CYTALUX™ (PAFOLACIANINE)
- Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable
- Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient
- History of anaphylactic reaction
- History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid
- Pregnancy, or positive pregnancy test
Show all 11Show fewer
- Clinically significant abnormalities on ECG
- Impaired renal function defined as eGFR <50 mL/min/1.73m2
- Impaired liver function defined as values >3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin
- Received an investigational agent in another trial within 30 days prior to surgery
- Known sensitivity to fluorescent light
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Maheswari Senthil, MD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study
This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.
- Conditions
- Gastrointestinal Cancer, Peritoneal Carcinomatosis
- Being tested
- Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
- Medical subject headings
- Gastrointestinal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imagingDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Pafolacianine (CYTALUX) | Experimental | All subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery. Receives: Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytoreduction (CC) Score
Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection.
Measured: 1 year
Sensitivity-True Positive Rate (TPR)
Sensitivity, or the True Positive Rate (TPR), is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be gastrointestinal cancer (and folate receptor (FR) positive) by central pathology relative to the total number of lesions confirmed to be gastrointestinal cancer (FR+) by central pathology, that is proportion of cancerous lesions that are fluorescent light positive.
Measured: 1 year
Specificity-True Negative Rate (TNR)
Specificity, or the True Negative Rate (TNR), is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology, relative to the total number of lesions that are negative for gastrointestinal cancer (FR-) by central pathology-that is, the proportion of non-cancer lesions that are fluorescent light negative.
Measured: 1 year
Positive Predictive Value (PPV)
Positive Predictive Value (PPV) is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology relative to the total number of lesions removed that are fluorescent light positive-that is, the proportion of fluorescent light positive lesions that are cancerous.
Measured: 1 year
Negative Predictive Value (NPV)
Negative Predictive Value (NPV) is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to the total number of lesions removed that are fluorescent light negative-that is, the proportion of fluorescent light negative lesions that are histologically negative for cancer.
Measured: 1 year
Accuracy
Accuracy is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology and the fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to all lesions sampled.
Measured: 1 year
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence rates of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) from the time of CYTALUX (PAFOLACIANINE) injection administration through the conclusion of study participation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start13 Nov 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- On Target Laboratories
- Responsible party
- Principal investigator, Maheswari Senthil, MD, University of California, Irvine
- Investigators
- Maheswari Senthil, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511037
- Sponsor's protocol ID
- 4951
- Other IDs
- UCI 23-184
- Status last verified
- Feb 2026
- First submitted
- 15 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study
- ClinicalTrials.gov ID
- NCT06511037
- Acronym / sponsor ID
- 4951
- Conditions
- Gastrointestinal Cancer, Peritoneal Carcinomatosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- On Target Laboratories
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 19 Jul 2024 (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 pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pafolacianine (CYTALUX) | Experimental | Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imagingAll subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients 18 years of age and older
- Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery
- Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery
- Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion
- Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by study restrictions
Key exclusion criteria (11 listed)
- Previous exposure to CYTALUX™ (PAFOLACIANINE)
- Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable
- Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient
- History of anaphylactic reaction
- History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid
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 |
|---|---|---|
| Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imagingGiven IV | Drug | Pafolacianine (CYTALUX) |
Primary outcome
Cytoreduction (CC) Score
Time frame: 1 year
Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection.
Sensitivity-True Positive Rate (TPR)
Time frame: 1 year
Sensitivity, or the True Positive Rate (TPR), is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be gastrointestinal cancer (and folate receptor (FR) positive) by central pathology relative to the total number of lesions confirmed to be gastrointestinal cancer (FR+) by central pathology, that is proportion of cancerous lesions that are fluorescent light positive.
Specificity-True Negative Rate (TNR)
Time frame: 1 year
Specificity, or the True Negative Rate (TNR), is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology, relative to the total number of lesions that are negative for gastrointestinal cancer (FR-) by central pathology-that is, the proportion of non-cancer lesions that are fluorescent light negative.
Positive Predictive Value (PPV)
Time frame: 1 year
Positive Predictive Value (PPV) is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology relative to the total number of lesions removed that are fluorescent light positive-that is, the proportion of fluorescent light positive lesions that are cancerous.
Negative Predictive Value (NPV)
Time frame: 1 year
Negative Predictive Value (NPV) is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to the total number of lesions removed that are fluorescent light negative-that is, the proportion of fluorescent light negative lesions that are histologically negative for cancer.
Accuracy
Time frame: 1 year
Accuracy is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology and the fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to all lesions sampled.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 30 days
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 27 Feb 2026.
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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.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Maheswari Senthil, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging in people with Gastrointestinal Cancer and Peritoneal Carcinomatosis, run by University of California, Irvine 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 5 inclusion and 11 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 27 Feb 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytoreduction (CC) Score (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.