New imaging technique targets Hard-to-Find cancers
NCT ID NCT05737615
First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 4 times
Summary
This study aimed to test a new two-step PET imaging method to better detect cancers that produce a substance called CA19-9, such as pancreatic, bladder, and gastrointestinal tumors. The plan was to give patients an antibody followed by a radioactive tracer to highlight cancer cells. However, the trial was withdrawn before any patients were enrolled, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hu5B1-TCO and 64Cu-Tz-SarAr
- What this could lead to
- If successful, this could lead to a more precise way to detect certain cancers using PET scans.
- What could go wrong
- This trial was withdrawn before enrolling any participants, so no results are available. The approach is still very early and unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Started
-
Feb 2023
- Finished
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Aug 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients will be eligible for enrollment if they fulfill the following criteria: 1. Signed informed consent 2. 18 years of age or older 3. Histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma/bladder carcinoma / gastrointestinal tumor reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) of Patient with solid tumors increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy 4\. At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects 5. ECOG performance status of 0 to 2 6. Adequate laboratory parameters including: i. Absolute neutrophil count (ANC) ≥1.5 x 109/L ii. Hemoglobin ≥ 9.0 g/dL iii. Platelet count \>75,000/ mm3 iv. AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN v. 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 vi. Creatinine clearance (CLcr) (\> 60 mL/min) estimated by the Cockcroft-Gault (C-G) equation or estimated glomerular filtration rate (eGFR) 10. Willingness to participate in collection of pharmacokinetic samples Exclusion Criteria: Patients will be excluded from the study if they fulfill any of the following criteria: 1. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy 2. Major surgery other than diagnostic surgery within 4 weeks of Study Day 1 3. History of anaphylactic reaction to human, or humanized, antibody 4. Other on-going cancer therapy with investigational agents 5. Known history of HIV 6. Pregnant or currently breast-feeding a. Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the study and for 1 week following the study treatment. 7. Psychiatric illness/social situations that would interfere with compliance with study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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