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New Imaging Technique for Pancreatic Cancer

Phase 1
Recruiting
Led By Neeta Pandit-Taskar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled referred to surgery or biopsy as standard of care for their pancreatic adenocarcinoma
Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new imaging agent to see if it can better detect pancreatic cancer.

Who is the study for?
This trial is for adults with advanced pancreatic cancer or tumors that show a marker called CA19-9. They must be scheduled for surgery, have certain blood and organ function levels within set limits, and not be pregnant or breastfeeding. People with major recent surgeries, uncontrolled infections, HIV, or severe psychiatric issues cannot join.Check my eligibility
What is being tested?
The study tests an experimental imaging agent named 89Zr-DFO-HuMab-5B1 to see how well it attaches to pancreatic tumors during PET/CT scans. The goal is to improve the quality of tumor images in patients who are about to undergo surgery.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to the humanized antibody nature of MVT-2163 and MVT-5873. Specific side effects aren't listed but could relate to typical imaging contrast agents like mild pain, swelling at injection site, or rare anaphylactic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery or biopsy for my pancreatic cancer as part of my standard treatment.
Select...
My cancer is advanced pancreatic or CA19-9 positive.
Select...
I am recommended for surgery or biopsy for my IPMN condition.
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I can care for myself and am up and about more than 50% of my waking hours.
Select...
My pancreatic cancer is confirmed or highly suspected to be at stage T2 or T3.
Select...
My pancreatic cancer is confirmed or highly suspected and is at an intermediate stage.
Select...
I am scheduled for surgery for my pancreatic cancer or IPMN.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biodistribution of MVT-2163
Number of subjects with treatment-related adverse events as assessed

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT03801915
100%
Pleural effusion
100%
Hepatobiliary disorders - Other, Bile duct perforation
100%
Aspartate aminotransferase increased
100%
Blood bilirubin increased
100%
Creatinine increased
100%
Somnolence
100%
Urine output decreased
100%
Vomiting
100%
Abdominal infection
100%
Abdominal pain
100%
Confusion
100%
Lymphocyte count decreased
100%
Hyperkalemia
100%
Hypotension
100%
Alkaline phosphatase increased
100%
Alanine aminotransferase increased
100%
Anemia
100%
Dyspnea
100%
Hypoalbuminemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)

Trial Design

1Treatment groups
Experimental Treatment
Group I: 89Zr-DFO-HuMab-5B1 (MVT-2163) ImagingExperimental Treatment2 Interventions
All subjects will receive a single, fixed, intravenous dose of MVT-2163, consisting of 3 mg (nominal mass - actual mass administered will likely vary between 2.0 and 2.5 mg) of MVT-2163 radiolabeled from 5 mCi to no less than 1.0 mCi (adjusted as of 16-Mar 2017) of 89Zr.Cohort 1 subjects will receive MVT-2163, with no MVT-5873 pre-dosing. Subjects in subsequent cohorts 2 and 3 will receive a dose of MVT-5873 15 minutes, ~ 2 hours, and ~4 hours prior to administration of MVT-2163. Future cohorts 4 and 5 may evaluate alternate time frames. Other cohorts may evaluate administration of MVT-5873 one week prior (D-7) to the day of MVT-2163 administration and a second administration of MVT-5873 the day of (D0) MVT-2163 administration. The re-entry (RE) and pre-surgery (PS) cohorts will administer MVT-2163 3 ± 1 hour after administration of MVT-5873.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MVT-5873
2019
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,840 Total Patients Enrolled
BioNTech SEIndustry Sponsor
64 Previous Clinical Trials
107,666 Total Patients Enrolled
Neeta Pandit-Taskar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
311 Total Patients Enrolled

Media Library

MVT-5873 Clinical Trial Eligibility Overview. Trial Name: NCT04883775 — Phase 1
Pancreatic Cancer Research Study Groups: 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging
Pancreatic Cancer Clinical Trial 2023: MVT-5873 Highlights & Side Effects. Trial Name: NCT04883775 — Phase 1
MVT-5873 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883775 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment quota for this research project?

"Affirmative. Clinicaltrials.gov displays information that this medical trial is actively seeking participants - it was posted on May 10th 2021 and last updated on 3rd May 2022. The research calls for 15 volunteers from 7 locations to take part in the study."

Answered by AI

Are there a number of sites conducting this investigation in the same state?

"Currently, Memorial Sloan Kettering Westchester (Consent only) in Harrison, Memorial Sloan Kettering Bergen (Consent only ) in Montvale, and Memorial Sloan Kettering Nassau (Consent Only) in Uniondale are the three primary locations for recruitment into this trial. There are also 7 other sites that are accepting patients as well."

Answered by AI

Has MVT-5873 met the standards for governmental authorization?

"Our team at Power gave MVT-5873 a rating of 1 due to the limited clinical data available relating to safety and efficacy associated with this Phase 1 trial."

Answered by AI

Is the enrollment period of this clinical trial still ongoing?

"According to data found on clinicaltrials.gov, this research is presently accepting applicants - it was initially posted on May 10th 2021 and recently updated on May 3rd 2022."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of a New Technique for Imaging Pancreatic Cancer
2021. "Study of a New Technique for Imaging Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04883775.
~4 spots leftby May 2025
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