Study of a New Technique for Imaging Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    May 12, 2023
  • participants needed
    15
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 12 May 2022
platelet count
carcinoma
neutrophil count
pancreatic adenocarcinoma
EGFR
adenocarcinoma
pdac
pancreatic neoplasm
pancreatic ductal adenocarcinoma
breast ductal carcinoma
ca19-9
intraductal papillary mucinous neoplasm

Summary

The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer.

Details
Condition Pancreatic Cancer, Tumors That Express CA19-9
Treatment MVT-5873, MVT-2163
Clinical Study IdentifierNCT04883775
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

PART I : ESCALATION, EXPANSION, RE-ENTRY COHORTS
Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
PART II: PRE-SURGERY COHORT ONLY
Biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3) and
Patient scheduled to undergo surgery as standard of care for their pancreatic adenocarcinoma OR
Patients with Intraductal papillary mucinous neoplasm (IPMN) scheduled to undergo surgery as standard of care
The suspicion for pancreatic carcinoma and decision for surgery will be based on review of
imaging and clinical findings in the disease management team discussion including surgeon
and radiologist
PART I and II
Signed, informed consent
Age 18 or more years
At least one lesion by CT or MRI ≥ 2 cm, unless determine otherwise for pre-surgery
CA19-9 serum level
cohort subjects
For Part I: >ULN or CA19-9 positive biopsy (optional)
For Part II ( presurgical cohort): CA19-9 serum level (normal or high levels are
ECOG performance status of 0 to 2
allowed) or CA19-9 positive biopsy (optional)
Adequate laboratory parameters including
Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
Platelet count >75,000/ mm^3
Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior
days)
AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then
PART I: ESCALATION, EXPANSION, RE-ENTRY COHORTS
≤5.0 x ULN
Willingness to participate in collection of pharmacokinetic samples
Total bilirubin ≤1.5x the upper limit of normal unless considered due to
Gilbert's syndrome in which case, ≤3x the upper limit of normal
Creatinine (serum or plasma) ≤ 1.5 x ULN or eGFR>50 mL/min

Exclusion Criteria

Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
History of anaphylactic reaction to human, or humanized, antibody
Other on-going cancer therapy or investigational agents (except MVT-5873)
Known history of HIV
Pregnant or currently breast-feeding
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy
Psychiatric illness/social situations that would interfere with compliance with study
requirements
Prior entry onto this protocol 3 or more times (e.g., subjects may enter this protocol
and be imaged up to 3 times)
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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