CClinicalTrials.gg
CompletedNCT02092948Updated Jul 27, 2020

Phase I Study to evaluate124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer

A Phase 1 interventional study of [124I] PSCA-Minibody PET/CT imaging of the whole body in Prostate Cancer, Pancreatic Cancer and Bladder Cancer, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-27.

Sponsored by Jonsson Comprehensive Cancer Center · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2013, registered Mar 2014).
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to determine whether positron emission tomography (PET), using the new imaging drug [124 I] PSCA-Minibody can be used for imaging prostate, pancreatic or bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs, etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder cancers.

Read the detailed description

The people doing this study want to find out:

  1. Can the [124 I] PSCA-Minibody be used to image prostate, pancreatic and bladder cancer?
  2. How much of the PSCA Minibody needs to be used to see the prostate, pancreatic or bladder cancer?
  3. Does the PSCA Minibody see more/same/fewer lesions than are identified on traditional scans such as bone scan or CT scan?

To answer these questions, we want to evaluate how [124 I] PSCA-Minibody is distributed throughout the body in 20 patients with prostate, pancreatic or bladder cancer. This is done with PET/CT imaging. A PET/CT scan is a non-invasive x-ray test that uses a special camera to take pictures of the inside of your body. It can "see" the radiation given off by tiny particles called positrons in the radioactive drug injected into you while also taking pictures of the organs within the body. For this study the radioactive substance is [124 I] PSCA-Minibody.

The scanning for this study is done with an imaging procedure in the department of Nuclear Medicine during which the experimental drug [124 I] PSCA-Minibody will be administered by intravenous (i.v.) infusion. An experimental drug is one that is not yet approved by the US Food and Drug Administration (FDA). [124 I] PSCA-Minibody is a combination of a monoclonal antibody, and I-124, a radioactive type of iodine. The iodine will make the antibody and the cancer cells visible in a PET scan. PET stands for positron emission tomography and uses radioactivity to image the inside of the body. A CT scan uses x-rays to look at the internal organs in the body. This study will use a combination PET/CT to look at the cancer cells in your body that have taken up the study agent as well as to see their location in your body.

02

Conditions studied

  • Prostate Cancer
  • Pancreatic Cancer
  • Bladder Cancer

Keywords

  • metastatic
  • PSCA
  • minibody
  • PET/CT
03

In context

Pancreatic Neoplasms

3,236 studies on the registry are indexed under Pancreatic Neoplasms; 900 are open to participants now.

This study's enrollment of 8 is below the median of 46 across 2,425 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria (subjects must meet all of the following criteria in order to be enrolled in this study):

  1. Histological diagnosis of prostate, bladder or pancreatic cancer.
  2. Evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI, or FDG-PET within 6 weeks (with no new interval treatment before imaging trial)
  3. Expected survival ≤ 6 months
  4. Provide written informed consent and willing to comply with protocol requirement
  5. ≥ 18 years of age
  6. The following laboratory results should be within the following limits within 4 weeks prior to study day 1:

    1. PSA > 5 (only for prostate cancer patients)
    2. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/l
    3. Platelet count ≥ 100 x 10\^9/l
    4. Serum bilirubin ≤ 2.0 mg/dl
    5. Aspartate amino transaminase (AST) ≤ 2.5 x ULN
    6. Alanine aminotransferase (ALT) ≤ 2.5 x ULN
    7. Serum creatinine ≤ 2.0 mg/dl (calculated creatinine clearance > 45 ml/min)
  7. Able to undergo imaging studies, as well as conventional bone and body imaging, as well as 124I-A11 PSCA minibody experimental scan.

Exclusion Criteria (subjects meeting any of the following criteria will not be enrolled in this study):

  1. Inadequate venous access (two antecubital or equivalent venous access sites)
  2. Administration of a radionuclide within 5 physical half-lives prior to projected administration of 124I-A11 PSCA minibody
  3. New York Heart Association Class III/IV cardiac disease.
  4. History of autoimmune hepatitis
  5. Treatment with any experimental therapy within 30 days prior to enrollment or current participation in any other interventional clinical study
  6. Subjects weighing ≥ 350 lbs or are unable to fit in the imaging gantry
  7. Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.
  8. Iodine Allergy, hyperthyroidism, or Grave's disease.
  9. Any other disease or medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    All patients

    Patients will receive one intravenous dose of 4 mg, 20mg or 40 mg of A11 minibody labeled with 5 mCi (185 MBq) of 124I, followed by \[124I\] PSCA-Minibody PET/CT imaging of the whole body.

    Radiation: [124I] PSCA-Minibody PET/CT imaging of the whole body

Interventions

  • Radiation[124I] PSCA-Minibody PET/CT imaging of the whole body

    Whole body Imaging

06

What researchers measure

Primary outcomes

  1. Assess the safety of [124I] PSCA-Minibody

    Safety measures: adverse events including laboratory adverse events will be graded and summarized according to the National Cancer Institute CTCAE, version 4.03. * Laboratory tests (CBC with differential, platelets, serum electrolytes, BUN, creatinine, chemistry, urine analysis) * Vital signs (upright and supine blood pressure, heart rate, respiratory rate, oral temperature, and weight) * Physical examination * HAMBA tier in serum

    Time frame: up to 3 months

Secondary outcomes

  1. Assess the ability of [124I] PSCA-Minibody to image known metastatic disease

    Binary qualitative reading of \[124I\] PSCA-Minibody based PET imaging in subjects with known metastatic prostate, pancreatic, or bladder cancer to decide on the presence or absence of targeting to this cancer.

    Time frame: 1 Day of scan

  2. Compare the sensitivity and specificity of [124I] PSCA-Minibody with conventional imaging

    Number, localization and size of metastatic lesions by 124I-A11 based PET/CT imaging and comparison to standard of care imaging with CT and bone scan.

    Time frame: 1 Day of scan

07

Study locations

1 site
  • University of California, Los Angeles
    Los Angeles, California 90024, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02092948
Lead sponsor
Jonsson Comprehensive Cancer Center
Collaborators
ImaginAb, Inc.
Responsible party
Sponsor
First posted
Mar 20, 2014
Start date
Aug 22, 2013
Primary completion
Jan 6, 2017
Completion
Jan 6, 2017
Last update
Jul 27, 2020

Study contacts

Alan Pantuck, MD
principal investigator · Jonsson Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion