Sentinel Lymph Node BiopsyPhase 2NCT05457842
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery
A Phase 2 study testing pudexacianinium chloride in people with Sentinel Lymph Node Biopsy and Breast Cancer, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control. Melanoma was a type of skin cancer that starts in cells called melanocytes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sentinel Lymph Node Biopsy, Breast Cancer, Melanoma
- What is being tested?
- pudexacianinium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2022to 20 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant has been diagnosed with localized breast cancer (female only, stage 1 to 2, N0 and M0) or melanoma (stage 1 to 2, N0 and M0) and is scheduled to undergo surgical intervention for systemic lymph node (SLN) detection and removal using Technetium-99m sulfur colloid or Lymphoseek as part of Standard of Care (SOC).
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study treatment administration.
- Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final study treatment administration.
- Female participant must not donate ova starting at first dose of Investigational Product (IP) and throughout the study period and for 30 days after final study treatment administration.
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- Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use of contraception throughout the treatment period and for 30 days after final study treatment administration.
- Male participant must not donate sperm during the treatment period and for 30 days after final study treatment administration.
- Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final study treatment administration.
- Participant agrees not to participate in another interventional study while participating in the present study.
Who cannot join
- Participant has had prior lymph node (LN) surgery in the area where LN detection is needed.
- Participant has had prior LN radiation in the area where LN detection is needed.
- Participant has had prior neo-adjuvant chemotherapy.
- Participant has definitive LN metastases.
- Participant has metastatic cancer.
- Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
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- Participant has any condition which makes the participant unsuitable for study participation.
- Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
- Participant has had previous exposure to ASP5354.
- Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III-IV) or other medical conditions that would impact safety or study compliance.
- Participant has a resting heart rate <= 45 beats per minute (bpm) or >=115 bpm, systolic blood pressure >=160 mm Hg or diastolic blood pressure >= 100 mm Hg within 1 week prior to IP administration. If the blood pressure exceeds the limits above, repeat readings can be taken. Participant who has adequately controlled blood pressure is eligible.
- Participant has any of the screening laboratory values outside of the protocol specification criteria.
- Participant has received ICG, other near-infrared fluorescence (NIR-F) imaging agents, Blue dye (e.g., methylene blue or isosulfan blue) or magtrace within 2 weeks prior to IP administration.
- Participant has active alcohol abuse or illicit drug use (non-prescription or over-the-counter medications). Participant should not have consumed any alcohol or illicit drug (excluding cannabidiol products) within 24 hours of surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI Irvine Health-Chao Family Comprehensive Cancer Center Cancer
Orange, California, 92868
About this study
Official title: A Phase 2 Open-label, Dose-finding Study to Determine the Optimal Dose for Lymph Node Visualization Using ASP5354 in Participants With Breast Cancer or Melanoma Undergoing Sentinel Lymph Node Biopsy
This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control. Melanoma was a type of skin cancer that starts in cells called melanocytes. These cells made a substance called melanin which gives the skin its color. In this study, people had surgery to remove the lymph node closest to the site of their cancer. This lymph node was called the sentinel node. This was done to check if the cancer had spread from the original site to the sentinel node. This procedure was called a sentinel node biopsy.
This study provided more information on a potential new dye, called ASP5354, used in sentinel node biopsies. ASP5354 helped to show the lymph nodes more clearly during surgery. This helped the surgeon find the lymph node closest to the site of the cancer (sentinel node).
Read more
The main aim of the study was to find the best dose of ASP5354 that clearly showed the lymph nodes during surgery. This was an open-label study. That means each person in the study and the study doctors knew that person received ASP5354.
Each person only received 1 dose of ASP5354.
People that wanted to take part in the study were checked by a study doctor. This was on a separate visit before their surgery. Before surgery, people who took part in the study were asked if they had any other medical problems. They had a physical exam, an ECG to check their heart rhythm, and had their vital signs checked (blood pressure, pulse rate, and breathing rate). Other checks included some blood and urine samples taken for laboratory tests.
During surgery, a study surgeon injected ASP5354 near the cancer site. They recorded how clearly they could see the lymph nodes. Some blood samples were taken for laboratory tests and an ECG was done. After their surgery, people were asked if they have any other medical problems.
People returned to the hospital 9 days later for a check-up. The check-up included a physical exam, an ECG to check their heart rhythm, and a check of their vital signs (blood pressure, pulse rate, and breathing rate). Other checks included some blood samples taken for laboratory tests. People were asked if they had any medical problems and asked to complete a feedback survey.
- Conditions
- Sentinel Lymph Node Biopsy, Breast Cancer, Melanoma
- Being tested
- pudexacianinium chloride
- Keywords
- ASP5354, pudexacianinium chloride, SLN, Breast Cancer, Melanoma
- Medical subject headings
- Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pudexacianinium chlorideDrug
Also called ASP5354
Intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| ASP5354 0.2 mg | Experimental | Participant received a single dose of 0.2 milligrams (mg) intradermal injection of ASP5354 on day 1. Receives: Drug: pudexacianinium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Dose of ASP5354 for Lymph Node (LN) Visualization
The optimal dose was defined as the dose that provided a better visualization compared with lower doses and a comparable visualization to the next higher dose. In the case where 2 doses performed equally, the lower dose was selected. Cumulative visualization data of the LNs from all treated participants was used for optimal dose determination. The optimal dose was determined by the Visualization Review Committee (VRC) using data from the following assessments: LN tissue visualized (Y/N), visualized tissue is lymphatic in origin based on pathologic confirmation, Likert Scale determination of the intensity of fluorescence, and proportion of identified LN with histopathologic confirmation of LN tissue by ASP5354 compared with standard of care (SOC) treatment.
Measured: Day 1
Secondary outcomes (4)
Percentage of Participants With at Least 1 LN Detected Using ASP5354
The visualization of at least 1 LN with histopathologic confirmation is assessed by using a binary "Yes" or "No" question. Those participants with "Yes" as response was reported.
Measured: Day 1 up to day 10
Percentage of Identified LN Tissue by ASP5354 Compared With SOC Treatment
The percentage of identified LN with ASP5354 will be compared with SOC treatment with either Tc-99mSC or Lymphoseek, through histopathologic confirmation.
Measured: Day 1 up to day 10
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as an AE observed after starting administration of the study drug.
Measured: From first dose up to day 10
Plasma Concentration of ASP5354
Plasma concentration of ASP5354. The Lower limit of quantification (LLOQ) was defined as 1.00 nanograms per milliliter (ng/mL). Measured values below the LLOQ were expressed as <LLOQ and not reported.
Measured: Predose, approximately 10 minutes, 30 minutes, 60 minutes postdose, and at the end of surgery (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start10 Aug 2022
- Primary completion2 Sep 2022
- Study completion20 Sep 2022
Why it stopped: Company's strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sentinel Lymph Node BiopsyStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457842
- Sponsor's protocol ID
- 5354-CL-1201
- Status last verified
- Nov 2024
- First submitted
- 11 Jul 2022
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label, Dose-finding Study to Determine the Optimal Dose for Lymph Node Visualization Using ASP5354 in Participants With Breast Cancer or Melanoma Undergoing Sentinel Lymph Node Biopsy
- ClinicalTrials.gov ID
- NCT05457842
- Acronym / sponsor ID
- 5354-CL-1201
- Conditions
- Sentinel Lymph Node Biopsy, Breast Cancer, Melanoma
- Keywords
- ASP5354, pudexacianinium chloride, SLN, Breast Cancer, Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company's strategic decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Posted 1 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control. Melanoma was a type of skin cancer that starts in cells called melanocytes. These cells made a substance called melanin which gives the skin its color. In this study, people had surgery to remove the lymph node closest to the site of their cancer. This lymph node was called the sentinel node. This was done to check if the cancer had spread from the original site to the sentinel node. This procedure was called a sentinel node biopsy.
This study provided more information on a potential new dye, called ASP5354, used in sentinel node biopsies. ASP5354 helped to show the lymph nodes more clearly during surgery. This helped the surgeon find the lymph node closest to the site of the cancer (sentinel node).
The main aim of the study was to find the best dose of ASP5354 that clearly showed the lymph nodes during surgery. This was an open-label study. That means each person in the study and the study doctors knew that person received ASP5354.
Each person only received 1 dose of ASP5354.
People that wanted to take part in the study were checked by a study doctor. This was on a separate visit before their surgery. Before surgery, people who took part in the study were asked if they had any other medical problems. They had a physical exam, an ECG to check their heart rhythm, and had their vital signs checked (blood pressure, pulse rate, and breathing rate). Other checks included some blood and urine samples taken for laboratory tests.
During surgery, a study surgeon injected ASP5354 near the cancer site. They recorded how clearly they could see the lymph nodes. Some blood samples were taken for laboratory tests and an ECG was done. After their surgery, people were asked if they have any other medical problems.
People returned to the hospital 9 days later for a check-up. The check-up included a physical exam, an ECG to check their heart rhythm, and a check of their vital signs (blood pressure, pulse rate, and breathing rate). Other checks included some blood samples taken for laboratory tests. People were asked if they had any medical problems and asked to complete a feedback survey.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP5354 0.2 mg | Experimental | Drug: pudexacianinium chlorideParticipant received a single dose of 0.2 milligrams (mg) intradermal injection of ASP5354 on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant has been diagnosed with localized breast cancer (female only, stage 1 to 2, N0 and M0) or melanoma (stage 1 to 2, N0 and M0) and is scheduled to undergo surgical intervention for systemic lymph node (SLN) detection and removal using Technetium-99m sulfur colloid or Lymphoseek as part of Standard of Care (SOC).
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final study treatment administration.
- Female participant must not donate ova starting at first dose of Investigational Product (IP) and throughout the study period and for 30 days after final study treatment administration.
- Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use of contraception throughout the treatment period and for 30 days after final study treatment administration.
Key exclusion criteria (14 listed)
- Participant has had prior lymph node (LN) surgery in the area where LN detection is needed.
- Participant has had prior LN radiation in the area where LN detection is needed.
- Participant has had prior neo-adjuvant chemotherapy.
- Participant has definitive LN metastases.
- Participant has metastatic cancer.
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 |
|---|---|---|
| pudexacianinium chlorideAlso: ASP5354Intradermal injection | Drug | ASP5354 0.2 mg |
Primary outcome
Optimal Dose of ASP5354 for Lymph Node (LN) Visualization
Time frame: Day 1
The optimal dose was defined as the dose that provided a better visualization compared with lower doses and a comparable visualization to the next higher dose. In the case where 2 doses performed equally, the lower dose was selected. Cumulative visualization data of the LNs from all treated participants was used for optimal dose determination. The optimal dose was determined by the Visualization Review Committee (VRC) using data from the following assessments: LN tissue visualized (Y/N), visualized tissue is lymphatic in origin based on pathologic confirmation, Likert Scale determination of the intensity of fluorescence, and proportion of identified LN with histopathologic confirmation of LN tissue by ASP5354 compared with standard of care (SOC) treatment.
4 secondary outcomes
Percentage of Participants With at Least 1 LN Detected Using ASP5354
Time frame: Day 1 up to day 10
Percentage of Identified LN Tissue by ASP5354 Compared With SOC Treatment
Time frame: Day 1 up to day 10
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Time frame: From first dose up to day 10
Plasma Concentration of ASP5354
Time frame: Predose, approximately 10 minutes, 30 minutes, 60 minutes postdose, and at the end of surgery (day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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. This study is not recruiting at the moment.
Medical Monitor study director
Astellas Pharma Inc
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 pudexacianinium chloride in people with Sentinel Lymph Node Biopsy and Breast Cancer, run by Astellas Pharma Inc 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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 20 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Dose of ASP5354 for Lymph Node (LN) Visualization (time frame: Day 1). 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 20 Nov 2024.