AzTrials
AzTrials

Prostatic NeoplasmsEarly Phase 1NCT02391025

Gallium-68 Citrate PET Used in Prostate Cancer

A Early Phase 1 study testing Gallium-68 citrate and Positron Emission Tomography (PET) in people with Prostatic Neoplasms, run by Rahul Aggarwal at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a single center, pilot, cross-sectional imaging study investigating the use of gallium-68 citrate PET in participants with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Gallium-68 citrate and Positron Emission Tomography (PET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
28 May 2015to 15 Jun 2023
Phase
Early 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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male participants with histologically confirmed prostate cancer
  • Participants must have castrate levels of testosterone (< 50 ng/dL) on Luteinizing hormone-releasing hormone (LHRH) analogue or have had prior bilateral orchiectomy, with evidence of castration-resistant disease by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria
  • Age 18 years or older at the time of study entry
  • Minimum of at least three discrete metastatic lesions in the bone and/or soft tissue amenable to whole body Positron Emission Tomography (PET) imaging per the judgment of study radiologist
  • For participants who undergo optional metastatic tumor biopsy following completion of gallium citrate PET:
  • Presence of one or more metastases by standard radiographic scans that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology

Who cannot join

  • Contra-indications to MRI, including permanent pacemaker, implantable device, aneurysm clip, or severe claustrophobia (for participants planning to be imaged on PET/ Magnetic resonance imaging(MRI) scanner)
  • Active infection within 14 days of study enrollment
  • For participants who undergo optional metastatic tumor biopsy following completion of gallium citrate PET:
  • History of radiation therapy to the target metastatic lesion selected for tumor biopsy
  • Contra-indication to biopsy including uncontrolled bleeding diathesis.
  • Platelets >75,000/μl and prothrombin time (PT) or international normalized ratio (INR) and a partial prothrombin time (PTT) < 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Gallium-68 Citrate PET To Detect MYC Amplification in Metastatic Castrate Resistant Prostate Cancer

This is a single center, pilot, cross-sectional imaging study investigating the use of gallium-68 citrate PET in participants with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519).

The study population will consist of participants with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition.

Read the detailed description

Primary Objective:

  1. To determine the association between maximum average of standard uptake value (SUVmax-ave) of target metastatic lesions on gallium-68 citrate PET with MYC amplification determined from analysis of circulating tumor DNA.

Secondary Objectives:

  1. To determine the accuracy rate, sensitivity, specificity of gallium citrate PET in the detection of metastatic lesions as compared to standard staging scans including cross-sectional imaging of the abdomen/pelvis and whole body bone scan.

II. To determine the optimal dose of gallium-68 citrate and timing of scan post-injection to maximize tumor-to-background signal.

III. To characterize the safety profile of gallium-68 citrate.

Outline:

The study will involve gallium-68 PET scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of gallium scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment that will be completed within 12 weeks of baseline gallium citrate PET.

Being tested
Gallium-68 citrate, Positron Emission Tomography (PET)
Keywords
Metastatic, Prostate Cancer, Castrate Resistant
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Gallium-68 citrateDrug

    Also called Gallium-68 (8^Ga) citrate, Ga-68 citrate

    Given via IV at time of imaging

  • Positron Emission Tomography (PET)Procedure or surgery

    Also called PET Scan

    Imaging procedure

Study groups in NCT02391025
Study groupRoleWhat they receive
Gallium-68 citrate, PETExperimentalParticipants will receive a single scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment received outside this study that will be completed within 12 weeks of baseline scan.
Receives: Drug: Gallium-68 citrate; Procedure: Positron Emission Tomography (PET)

What is being measured

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

  1. Mean maximum Standardized Uptake Value (SUVmax)

    The mean and standard deviation of SUVmax of gallium-68 citrate (across all metastatic lesions per participant) will be reported.

    Measured: Day of imaging (1 day)

  2. Mean maximum Standardized Uptake Value (SUVmax-ave)

    The mean and standard deviation of SUVmax-ave of gallium-68 citrate across all participants in the study cohort will be descriptively reported.

    Measured: Day of imaging (1 day)

Secondary outcomes (7)

  1. Correlation between SUVmax and MYC gene expression

    For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and MYC gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.

    Measured: Day of imaging (1 day)

  2. Correlation between SUVmax and transferrin receptor gene expression

    For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and transferrin receptor gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.

    Measured: Day of imaging (1 day)

  3. Mean SUVmax-ave percent change from baseline

    For participants who undergo optional follow up gallium-68 citrate PET scan, the mean percent change from baseline in SUVmax-ave will be descriptively reported.

    Measured: Up to 12 weeks

  4. Sensitivity of gallium-68 PET

    Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the sensitivity value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.

    Measured: Day of imaging (1 day)

  5. Specificity of gallium-68 PET

    Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the specificity of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.

    Measured: Day of imaging (1 day)

  6. Positive predictive value (PPV) of gallium-68 PET

    Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the positive predictive value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.

    Measured: Day of imaging (1 day)

  7. Number of participants with reported treatment-emergent adverse events

    The frequency and severity of adverse events following gallium-68 citrate injection will be descriptively reported, using CTCAE version 4.03.

    Measured: Up to 12 weeks

Timeline

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

  1. First posted18 Mar 2015 (estimated)
  2. Study start28 May 2015
  3. Primary completion15 Jun 2023
  4. Study completion15 Jun 2023

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
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02391025
Sponsor's protocol ID
145512
Other IDs
NCI-2017-01773
Status last verified
Jun 2023
First submitted
4 Mar 2015
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Gallium-68 citrate and Positron Emission Tomography (PET) in people with Prostatic Neoplasms, run by Rahul Aggarwal at 1 site 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean maximum Standardized Uptake Value (SUVmax) (time frame: Day of imaging (1 day)). The study lists 2 primary outcomes in all. 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 NCT02391025.

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 18 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in