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Breast CancerPhase 1NCT01362712

Exploratory, Phase I,Open Label,Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects

A Phase 1 study testing [F18]CP-18 Injection in people with Breast Cancer, run by Siemens Molecular Imaging at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This trial will be the first trial for the IP, [F-18]CP-18, and will be conducted as an exploratory Phase I trial designed to collect information as this IP is administered and evaluated for the first time in humans. Read more about this study

Who is it for?
Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
[F18]CP-18 Injection
How many people
7 participants
Where
3 sitesUnited States
Study dates
May 2011to Apr 2012
Phase
Phase 1
Are there results?
None posted in the registry

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 21 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For Normal Volunteers
  • Subject is a female or male of any race / ethnicity between 21 to 75 years old at the time of the investigational product administration
  • Subject or subject's legally acceptable representative provides written informed consent
  • Subject is capable of complying with study procedures
  • Subject must have renal functions values as defined by laboratory results within the following ranges:
  • Serum creatinine ≤ 2x institutional upper limits of normal
Show all 18Show fewer
  • For Cancer Patients
  • Patient is a female or male of any race / ethnicity between 21 to 75 years old at the time of the investigational product administration
  • Patients or subject's legally acceptable representative provides written informed consent
  • Patient is capable of complying with study procedures
  • Patient must have renal functions values as defined by laboratory results within the following ranges:
  • Serum creatinine ≤ 2x institutional upper limits of normal
  • BUN < 2X institutional upper limits of normal
  • Patient must have a confirmed diagnosis of stage IIB/IIIA/IIIB, locally advanced breast cancer
  • Patient has been or will be scheduled for the surgical resection of tumor(s) after undergoing neoadjuvant treatment and within approximately 7 days following the [F-18]CP-18 PET/CT scan
  • Patient has an adequate size breast tumor (≥1.0 cm) that should be amenable to imaging
  • Patient's tumor tissue is obtainable following surgery in order to perform immunohistochemistry staining using caspase 3 and/or other apoptosis biomarkers
  • Patient must have a previous baseline (pre-neoadjuvant treatment) diagnostic imaging exam including but not limited to MRI, CT, mammography, or [F-18] FDG PET/CT scan that identifies breast tumor location

Who cannot join

  • For Normal Volunteers
  • Subject is nursing
  • Subject is pregnant
  • Subject has been involved in an investigative, radioactive research procedure within the past 14 days
  • Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
  • For Cancer Patients
Show all 13Show fewer
  • Subject is nursing
  • Subject is pregnant
  • Subject has been involved in an investigative, radioactive research procedure within the past 14 days
  • Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
  • Patient tumor tissue(s) is not obtainable after tumor resection for caspase 3 and/or other biomarker immunohistochemistry assays
  • Patient has had or will have treatment intervention(s) between the [F-18]CP-18 PET/CT scan and tumor resection
  • Patient has a history or current evidence of any condition, therapy, lab abnormality that, in the opinion of the study investigator or treating physicians might confound the results of the study or poses an additional risk to the patients by their participation in the study

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of California, Irvine

    Irvine, California, 92697-5020

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: An Exploratory, Phase I, Open Label, Multi-Center, Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects

This trial will be the first trial for the IP, [F-18]CP-18, and will be conducted as an exploratory Phase I trial designed to collect information as this IP is administered and evaluated for the first time in humans. The trial will evaluate safety, biodistribution and dosimetry data in normal subjects and the trial will evaluate safety, biodistribution and tumor to background imaging data, and correlate image data with caspase 3 activity level on a surgical specimen analyzed by immunohistochemistry in the cancer subjects. All study results will be evaluated and analyzed in order to consider the design for future clinical trials. The information collected under this exploratory, Phase I study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.

Read the detailed description

The Sponsor intends to conduct this exploratory investigation of [F-18]CP-18 in human subjects. In this study of [F-18]CP-18, it is intended to assess its biodistribution, PET scan resolution, signal to background ratio in tumor, and any adverse events. This exploratory Phase I study will be used to obtain the necessary safety and dosimetry data in normal subjects and to collect drug biodistribution data, and tumor to background imaging data in breast cancer subjects. The information collected from this study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.

Conditions
Breast Cancer
Being tested
[F18]CP-18 Injection
Keywords
breast cancer, radiotherapy, chemoradiotherapy, radiation, chemoradiation, [F-18]
Medical subject headings
Breast Neoplasms

What participants receive

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

  • [F18]CP-18 InjectionRadiation

    Also called [F18]CP-18

    Normal volunteers dose will not exceed 20 mCi. For cancer subjects, the dose will be closer to 10 mCi.

What is being measured

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

  1. To collect biodistribution, dosimetry and metabolite profile of [F-18]CP-18 from normal subjects

    Measured: Visit 2 and Visit 3

Secondary outcomes (1)

  1. To collect pre-dose and post-dose parameters of vital signs, ECG and CBC and clinical chemistry data along with monitoring any adverse events of the IP from normal and cancer subjects.

    Measured: Visit 2 and Visit 3

Timeline

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

  1. First posted30 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2012
  4. Study completionApr 2012

Why it stopped: Unable to enroll breast cancer patients with current I/E criteria.

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 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01362712
Sponsor's protocol ID
CP-18 100
Status last verified
May 2012
First submitted
13 May 2011
Last updated
21 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • Doss M, Kolb HC, Walsh JC, Mocharla V, Fan H, Chaudhary A, Zhu Z, Alpaugh RK, Lango MN, Yu JQ. Biodistribution and radiation dosimetry of 18F-CP-18, a potential apoptosis imaging agent, as determined from PET/CT scans in healthy volunteers. J Nucl Med. 2013 Dec;54(12):2087-92. doi: 10.2967/jnumed.113.119800. Epub 2013 Oct 17.

    PubMed 24136934

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [F18]CP-18 Injection in people with Breast Cancer, run by Siemens Molecular Imaging at 3 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 18 inclusion and 13 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: stopped early, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Unable to enroll breast cancer patients with current I/E criteria.). Results are not available in the source record.

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?

To collect biodistribution, dosimetry and metabolite profile of [F-18]CP-18 from normal subjects (time frame: Visit 2 and Visit 3). 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 NCT01362712, 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 21 May 2012.

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