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Laparoscopic/Minimally Invasive Colorectal SurgeryPhase 2NCT04238481

A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

A Phase 2 study testing Pudexacianinium chloride in people with Laparoscopic/Minimally Invasive Colorectal Surgery, run by Astellas Pharma Inc at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery This study also investigated the safety, tolerability and the pharmacokinetics of ASP5354 in participants undergoing… Read more about this study

Who is it for?
Ages 18 years and older
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
13 participants
Where
2 sitesUnited States
Study dates
6 Oct 2020to 29 Nov 2021
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

  • Subject is scheduled to undergo laparoscopic/minimally invasive colorectal surgery.
  • Subject will need visualization of the ureter(s).
  • Female subject 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 subject must agree not to breastfeed starting at screening and throughout the study period.
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  • Female subject 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 subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after final study treatment administration.
  • Male subject must not donate sperm during the treatment period and for 30 days after final study treatment administration.
  • Male subject 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.
  • Subject agrees not to participate in another interventional study while participating in the present study.
  • Subjects enrolled after optimal dose determination:
  • Subject has any of the following values at screening:
  • Body mass index > 25
  • Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m^2 and < 60. Subjects with an eGFR ≥ 60 mL/min/1.73 m^2 may be considered after discussion with the medical monitor.

Who cannot join

  • Subject is anticipated to require ureteral stenting during surgery.
  • Subject has a history of known retroperitoneal fibrosis.
  • Subject has an active urinary tract infection.
  • Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Subject has any condition that makes the subject unsuitable for study participation.
  • Subject has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
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  • Subject has had previous exposure to ASP5354.
  • Subject has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III-IV) or other medical conditions that the investigator feels would impact safety or study compliance.
  • Subject has a mean resting heart rate ≤ 45 bpm or ≥ 115 bpm, mean systolic blood pressure (SBP) ≥ 160 mmHg or mean diastolic blood pressure (DBP) ≥ 100 mmHg on day -1. If the mean blood pressure exceeds the limits above, repeat readings can be taken. Subject who has adequately controlled blood pressure is eligible.
  • Subject has a mean corrected QT interval (Triplicate electrocardiogram [ECG]) using Fridericia's formula (QTcF) > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, the mean of 1 additional triplicate ECG may be taken.
  • Subject has any of the following screening laboratory values:
  • Hemoglobin ≤ 9 g/dL
  • Absolute neutrophil count ≤ 1500/µL
  • Platelet count ≤ 100000/µL
  • eGFR < 60 mL/min/1.73 m^2 (Not applicable to subjects enrolled after optimal dose determination.)
  • Serum bilirubin ≥ 2 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
  • Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
  • Subject has taken ICG or other near-infrared fluorescence (NIR)-F imaging agents within 48 hours prior to study treatment administration.
  • Subject has taken diuretics or inhibitors of renal transporters defined by Food and Drug Administration (FDA) within 48 hours prior to study treatment administration.
  • Subject has used any illicit drugs, unless legally prescribed and is not being abused (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 1 month prior to day -1.
  • Subject has a history of alcohol abuse. Subject should not have consumed any alcohol within 48 hours of surgery.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Center for Colon and Rectal Surgery; AdventHealth Medical Group

    Orlando, Florida, 32804

Other trials in United States

About this study

Official title: A Phase 2 Randomized Open-label, Dose-ranging Study for Ureter Visualization Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery This study also investigated the safety, tolerability and the pharmacokinetics of ASP5354 in participants undergoing laparoscopic/minimally invasive colorectal surgery.

Read the detailed description

Participants were randomly assigned at each dose level (dose A, B, C). During a standard minimally invasive surgery, visualization of the surgical field was assessed following the placement of the near infrared fluorescence (NIR F) imaging system proximal to the ureter of interest and then ASP5354 was administered.

Based on Visualization Review Committee (VRC) review of the initial 3 dose levels, if none of the doses selected had visualization, then additional two dose levels (dose D and E) was planned to be added; if 1 dose selected has visualization, then the dose level D was planned to be added. The dose level F was planned to be added if only the dose E level has visualization.

Being tested
Pudexacianinium chloride
Keywords
ASP5354, ureter visualization, imaging agent, near infrared fluorescence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pudexacianinium chlorideDrug

    Also called ASP5354

    Intravenous

Study groups in NCT04238481
Study groupRoleWhat they receive
Pudexacianinium chloride - Dose Level AExperimentalParticipants received single dose of pudexacianinium chloride at dose level A by intravenous (IV) bolus infusion on day 1 once the surgical area of interest is in view.
Receives: Drug: Pudexacianinium chloride
Pudexacianinium chloride - Dose Level BExperimentalParticipants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Receives: Drug: Pudexacianinium chloride
Pudexacianinium chloride - Dose Level CExperimentalParticipants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
Receives: Drug: Pudexacianinium chloride
Pudexacianinium chloride - Dose Level B - Dose ExpansionExperimentalParticipants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Receives: Drug: Pudexacianinium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s)

    The anatomical visualization of the index ureter(s) was assessed by the investigator intraoperatively using a binary "Yes or No" question on the ability to visualize the ureter and was assessed as successful, if both 30 minutes after pudexacianinium chloride dosing and at end of surgery the visualization was assessed as positive (Yes)/successful. For imputation of missing values at 30 minutes after pudexacianinium chloride administration, the nearest time points before and after the 30 minutes was considered. If both time points (before and after 30 minutes) were successful, 30 minutes anatomical visualization was imputed as successful. If both time points were not successful, then 30 minutes anatomical visualization was imputed as not successful, and all other cases were not imputed.

    Measured: 30 minutes postdose through end of surgery (on day 1)

Secondary outcomes (5)

  1. Number of Participants With Treatment Emergent Adverse Events

    An adverse event (AE) was any untoward medical occurrence in a participant administered an investigational product (IP), and which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP. A TEAE was defined as an AE observed after administration of the IP and up to the follow-up period. An AE was considered "serious" if the event: 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 (except for planned procedures as allowed per study) or leads to prolongation of hospitalization; Other medically important events.

    Measured: From first dose of study drug until follow-up period (day 10)

  2. Plasma Concentration of Pudexacianinium Chloride

    Plasma concentration of pudexacianinium chloride was reported from the blood samples collected. Concentrations below the lower limit of quantification (1 nanogram per milliliter [ng/mL]) are set to zero.

    Measured: Predose, 10, 30, 60, 90, 120 minutes, end of surgery, 180 mins post dose

  3. Urine Concentration of Pudexacianinium Chloride

    Urine concentration of pudexacianinium chloride was reported from the urine samples collected. Concentrations below the lower limit of quantification (20 ng/mL) are set to zero.

    Measured: Predose, 10, 30, 60, 90 minutes, end of surgery, 180 mins post dose

  4. Amount of Pudexacianinium Chloride Excreted in Urine (Ae) During Surgery

    Amount of pudexacianinium chloride excreted in urine during surgery was reported.

    Measured: During surgery (on day 1)

  5. Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%) During Surgery

    Percentage of pudexacianinium chloride dose excreted into urine during surgery was reported.

    Measured: During surgery (on day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start6 Oct 2020
  3. Primary completion18 Nov 2021
  4. Study completion29 Nov 2021

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04238481
Sponsor's protocol ID
5354-CL-0201
Status last verified
Aug 2023
First submitted
20 Jan 2020
Last updated
24 Oct 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Albert M, Delgado-Herrera L, Paruch J, Gerritsen-van Schieveen P, Kishimoto T, Takusagawa S, Cai N, Fengler J, Raizer J. Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery. Surg Endosc. 2023 Sep;37(9):7336-7347. doi: 10.1007/s00464-023-10193-9. Epub 2023 Jul 20.

    PubMed 37474823

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pudexacianinium chloride in people with Laparoscopic/Minimally Invasive Colorectal Surgery, run by Astellas Pharma Inc 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 15 inclusion and 22 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: finished, as of the sponsor's last update on 24 Oct 2024. 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?

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 13 Feb 2023). 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?

Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s) (time frame: 30 minutes postdose through end of surgery (on day 1)). 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 NCT04238481, which also lists 1 linked publication.

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 24 Oct 2024.

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