Endometrial CancerEarly Phase 1CYTALUX ISSNCT07278986
CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer
A Early Phase 1 study testing CYTALUX™ (pafolacianine) and 1788 4K Camera System with Advanced Imaging Modality in people with Endometrial Cancer and Near Infrared Fluorescence Imaging, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special camera system for the detection of cancer in patients undergoing surgical resection for endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Near Infrared Fluorescence Imaging, CYTALUX (Pafolacianine) Injection
- What is being tested?
- CYTALUX™ (pafolacianine) and 1788 4K Camera System with Advanced Imaging Modality
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2025to Feb 2029
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Adult subjects 18 years of age and older
- Primary diagnosis of endometrial cancer
- Scheduled to undergo surgery for endometrial cancer
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
- Willingness to stop the use of folate or folic acid supplements at least 48 hours prior to infusion of study drug
Who cannot join
- Pregnancy or positive pregnancy test
- Any medical condition that in the opinion of the investigator could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of CYTALUX
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Abramson Cancer Center at Penn Medicine
Philadelphia, Pennsylvania, 19104
Brianna Aguilar, 215-615-6770, Brianna.Aguilar@Pennmedicine.upenn.edu
Joseph Agyemang, 215-490-4121, joseph.agyemang@pennmedicine.upenn.edu
- Recruiting
University of Pennsylvania Gynecologic Oncology Department
Philadelphia, Pennsylvania, 19104
Brianna Aguilar, 215-615-6770, brianna.aguilar@pennmedicine.upenn.edu
Joseph Agyemang, 215-490-4121, joseph.agyemang@pennmedicine.upenn.edu
About this study
Official title: Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Imaging of Patients With Endometrial Cancer Planned for Surgery
The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special camera system for the detection of cancer in patients undergoing surgical resection for endometrial cancer.
Read the detailed description
Study participant's medical history (questions about their health) will be reviewed with them before their surgery to ensure they are able to participate in the study.
It is important for study participants to tell their doctor if they are taking vitamins that contain Folic Acid (vitamin B9), or Folic Acid (vitamin B9) supplements. They will need to stop taking these vitamins at least 48 hours before their scheduled infusion. Folic acid can reduce the effectiveness of the CYTALUX (pafolacianine). Certain other medications have not been studied together with CYTALUX (pafolacianine), so it is important for them to tell their doctor about all medicines and supplements they are taking.
Screening Visit (To see if they can take part in the study and will take place no more than 30 days before surgery)
The following will take place during the Screening Visit. These tests could include those that their doctor would do before any major surgery, in which case they may not be repeated for this trial.
- The doctor and/or a member of the doctor's team will ask them about their health, and obtain a list of all medications, including vitamins and over-the-counter medications (medicines obtained without a doctor's prescription), that they are taking.
Study Drug Infusion (Up to 7 days before surgery)
- Study participants will be scheduled to receive the drug being tested, CYTALUX (pafolacianine), any time from 7 days before their surgery up to the day of their surgery. They will receive CYTALUX (pafolacianine) at least one hour before the imaging portion of their surgery.
- Before they receive the study drug, the following will happen:
- The doctor and/or a member of the doctor's team will ask about their health and obtain a list of all medications including vitamins and over-the-counter (medicines obtained without a doctor's prescription) medicines that they are taking.
- For patients who are able to have children, a urine pregnancy test will be done.
- The study drug will be given over about 60 minutes through a vein. The dose of CYTALUX (pafolacianine) given will be calculated by their weight.
Surgery Visit
The following activities related to the study will happen on the day of surgery:
- The doctor will look for cancer as they usually do by feeling and looking throughout the peritoneal cavity using white light and will record the findings.
- After this, the doctor will use the special camera system to look for cancer that may light up where the CYTALUX (pafolacianine) has attached and will record the findings. Any cancer that is seen with the use of the special camera system may be the same as what the doctor recorded earlier without the use of the camera system, or there may be additional cancer seen.
- The doctor will then remove the cancer that has been detected, and any areas that they think should be taken out. This removal of the cancer will be done as the doctor would usually do in surgery for endometrial cancer.
- After the doctor has removed the cancer as discussed above, she/he will once again use the camera system to see if there is any cancer left and the findings will be recorded. Any such cancer observed will be removed based on the doctor's judgment.
- The cancer tissue that is removed will be sent to the lab for further testing.
- Any side effects that a participant may have with the use of CYTALUX (pafolacianine) and/or the camera system will be recorded.
- A sample of any cancer that is removed during this study will be sent to the hospital's laboratory for testing to see if it is endometrial cancer, and to see if the cancer has certain receptors on the surface that would cause the drug, CYTALUX (pafolacianine), to attach to the cancer.
Post-operation Visit (Day 28 ± 7 Days)
- About 4 weeks after the surgery, study participants will be contacted via phone by the doctor and/or a member of the doctor's team, or asked to come to the clinic.
- They will be asked about how they are feeling and about all the medications, including vitamins and over-the-counter (medicines obtained without a doctor's prescription) medicines, that they are taking. The findings will be recorded.
- Conditions
- Endometrial Cancer, Near Infrared Fluorescence Imaging, CYTALUX (Pafolacianine) Injection, Planned Diagnostic Laparoscopies
- Being tested
- CYTALUX™ (pafolacianine), 1788 4K Camera System with Advanced Imaging Modality
- Keywords
- Endometrial Cancer, Near Infrared Fluorescence Imaging, Cytalux (pafolacianine) injection, surgery, surgery planned, camera, investigational
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYTALUX™ (pafolacianine)Drug
CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease. Intraoperative imaging with Cytalux will be performed for assessment of disease detection in patients who are being evaluated to undergo surgery for endometrial cancer. Any tissues removed as part of standard of care will undergo assessment with NIR light imaging prior to and after resection. This will be then compared to gold standard histologic confirmation by pathology.
1788 4K Camera System with Advanced Imaging ModalityDevice
Combination Product
| Study group | Role | What they receive |
|---|---|---|
| CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease. | Other | single dose, open-label, pilot study of single dose of CYTALUX (pafolacianine) injection Receives: Drug: CYTALUX™ (pafolacianine); Device: 1788 4K Camera System with Advanced Imaging Modality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The primary efficacy endpoint is the sensitivity of CYTALUX with NIR imaging for detection of malignant lesions. Sensitivity is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be cancer relative to the total number of lesions confirmed to be cancer.
Sensitivity = (True Positive)/(True Positive + False Negative)
Measured: 2 months after surgery
Secondary outcomes (1)
Secondary Endpoints
- Incidence rates of all adverse events (AEs), adverse device effects (ADEs), and SAEs, from the time of CYTALUX administration through Visit 3
- Sensitivity for cancerous lesions for:
- FRα positive lesions
- FRβ positive lesions
Measured: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start18 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single center, single dose, open-label investigator-initiated pilot study in adult subjects with a primary diagnosis of endometrial cancer who are being evaluated for surgery. Subjects will receive one dose of CYTALUX™ (pafolacianine) injection intravenously prior to the planned diagnostic laparoscopies. This hour-long infusion will be completed from 1 hour to up to 168 hours (7 days) prior to intraoperative near-infrared (NIR) imaging for the planned surgery. All subjects participating in the study are expected to receive CYTALUX™ injection and standard care laparoscopic evaluation of disease. Intraoperative imaging with Cytalux will be performed for assessment of disease detection in patients who are being evaluated to undergo surgery for endometrial cancer. Any tissues removed as part of standard of care will undergo assessment with NIR light imaging prior to and after resection. This will be then compared to gold standard histologic confirmation by pathology.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278986
- Sponsor's protocol ID
- UPCC 22825
- Acronym
- CYTALUX ISS
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be shared without IPD.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Imaging of Patients With Endometrial Cancer Planned for Surgery
- ClinicalTrials.gov ID
- NCT07278986
- Acronym / sponsor ID
- CYTALUX ISS / UPCC 22825
- Conditions
- Endometrial Cancer, Near Infrared Fluorescence Imaging, CYTALUX (Pafolacianine) Injection, Planned Diagnostic Laparoscopies
- Keywords
- Endometrial Cancer, Near Infrared Fluorescence Imaging, Cytalux (pafolacianine) injection, surgery, surgery planned, camera, investigational
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 18 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 12 Dec 2025 (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.
The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special camera system for the detection of cancer in patients undergoing surgical resection for endometrial cancer.
Detailed description
Study participant's medical history (questions about their health) will be reviewed with them before their surgery to ensure they are able to participate in the study.
It is important for study participants to tell their doctor if they are taking vitamins that contain Folic Acid (vitamin B9), or Folic Acid (vitamin B9) supplements. They will need to stop taking these vitamins at least 48 hours before their scheduled infusion. Folic acid can reduce the effectiveness of the CYTALUX (pafolacianine). Certain other medications have not been studied together with CYTALUX (pafolacianine), so it is important for them to tell their doctor about all medicines and supplements they are taking.
Screening Visit (To see if they can take part in the study and will take place no more than 30 days before surgery)
The following will take place during the Screening Visit. These tests could include those that their doctor would do before any major surgery, in which case they may not be repeated for this trial.
- The doctor and/or a member of the doctor's team will ask them about their health, and obtain a list of all medications, including vitamins and over-the-counter medications (medicines obtained without a doctor's prescription), that they are taking.
Study Drug Infusion (Up to 7 days before surgery)
- Study participants will be scheduled to receive the drug being tested, CYTALUX (pafolacianine), any time from 7 days before their surgery up to the day of their surgery. They will receive CYTALUX (pafolacianine) at least one hour before the imaging portion of their surgery.
- Before they receive the study drug, the following will happen:
- The doctor and/or a member of the doctor's team will ask about their health and obtain a list of all medications including vitamins and over-the-counter (medicines obtained without a doctor's prescription) medicines that they are taking.
- For patients who are able to have children, a urine pregnancy test will be done.
- The study drug will be given over about 60 minutes through a vein. The dose of CYTALUX (pafolacianine) given will be calculated by their weight.
Surgery Visit
The following activities related to the study will happen on the day of surgery:
- The doctor will look for cancer as they usually do by feeling and looking throughout the peritoneal cavity using white light and will record the findings.
- After this, the doctor will use the special camera system to look for cancer that may light up where the CYTALUX (pafolacianine) has attached and will record the findings. Any cancer that is seen with the use of the special camera system may be the same as what the doctor recorded earlier without the use of the camera system, or there may be additional cancer seen.
- The doctor will then remove the cancer that has been detected, and any areas that they think should be taken out. This removal of the cancer will be done as the doctor would usually do in surgery for endometrial cancer.
- After the doctor has removed the cancer as discussed above, she/he will once again use the camera system to see if there is any cancer left and the findings will be recorded. Any such cancer observed will be removed based on the doctor's judgment.
- The cancer tissue that is removed will be sent to the lab for further testing.
- Any side effects that a participant may have with the use of CYTALUX (pafolacianine) and/or the camera system will be recorded.
- A sample of any cancer that is removed during this study will be sent to the hospital's laboratory for testing to see if it is endometrial cancer, and to see if the cancer has certain receptors on the surface that would cause the drug, CYTALUX (pafolacianine), to attach to the cancer.
Post-operation Visit (Day 28 ± 7 Days)
- About 4 weeks after the surgery, study participants will be contacted via phone by the doctor and/or a member of the doctor's team, or asked to come to the clinic.
- They will be asked about how they are feeling and about all the medications, including vitamins and over-the-counter (medicines obtained without a doctor's prescription) medicines, that they are taking. The findings will be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single center, single dose, open-label investigator-initiated pilot study in adult subjects with a primary diagnosis of endometrial cancer who are being evaluated for surgery. Subjects will receive one dose of CYTALUX™ (pafolacianine) injection intravenously prior to the planned diagnostic laparoscopies. This hour-long infusion will be completed from 1 hour to up to 168 hours (7 days) prior to intraoperative near-infrared (NIR) imaging for the planned surgery. All subjects participating in the study are expected to receive CYTALUX™ injection and standard care laparoscopic evaluation of disease. Intraoperative imaging with Cytalux will be performed for assessment of disease detection in patients who are being evaluated to undergo surgery for endometrial cancer. Any tissues removed as part of standard of care will undergo assessment with NIR light imaging prior to and after resection. This will be then compared to gold standard histologic confirmation by pathology.
| Arm | Type | Receives |
|---|---|---|
| CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease. | Other | Drug: CYTALUX™ (pafolacianine), Device: 1788 4K Camera System with Advanced Imaging Modalitysingle dose, open-label, pilot study of single dose of CYTALUX (pafolacianine) injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Adult subjects 18 years of age and older
- Primary diagnosis of endometrial cancer
- Scheduled to undergo surgery for endometrial cancer
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
Key exclusion criteria (5 listed)
- Pregnancy or positive pregnancy test
- Any medical condition that in the opinion of the investigator could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of CYTALUX
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
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 |
|---|---|---|
| CYTALUX™ (pafolacianine)CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease. Intraoperative imaging with Cytalux will be performed for assessment of disease detection in patients who are being evaluated to undergo surgery for endometrial cancer. Any tissues removed as part of standard of care will undergo assessment with NIR light imaging prior to and after resection. This will be then compared to gold standard histologic confirmation by pathology. | Drug | CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease. |
| 1788 4K Camera System with Advanced Imaging ModalityCombination Product | Device | CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease. |
Primary outcome
Primary Endpoint
Time frame: 2 months after surgery
The primary efficacy endpoint is the sensitivity of CYTALUX with NIR imaging for detection of malignant lesions. Sensitivity is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be cancer relative to the total number of lesions confirmed to be cancer. Sensitivity = (True Positive)/(True Positive + False Negative)
1 secondary outcome
Secondary Endpoints
Time frame: 2 months after surgery
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 12 Dec 2025.
- Individual participant dataSharing planned: No. Data will be shared without IPD.
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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.
2 sites 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 CYTALUX™ (pafolacianine) and 1788 4K Camera System with Advanced Imaging Modality in people with Endometrial Cancer and Near Infrared Fluorescence Imaging, run by Abramson Cancer Center at Penn Medicine at 2 sites 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 6 inclusion and 5 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Brianna Aguilar (215-615-6770, brianna.aguilar@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 2 months after surgery). 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 12 Dec 2025.