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Bladder CancerNCT01655745

Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer

A study testing FDG PET/MR in people with Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center 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
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Trial summary

This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
FDG PET/MR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
24 Jul 2012to 1 Feb 2019
Phase
Interventional
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age (no upper age limit)
  • Informed consent obtained and signed
  • cT2/T3-N0-M0 urothelial carcinoma of the bladder
  • Planned radical cystectomy with pelvic lymph node dissection
  • No known local regional or distant metastatic disease
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI

Who cannot join

  • History of severe reaction to contrast-enhanced CT scan
  • Poorly controlled diabetes mellitus
  • Inability to tolerate PET and/or MRI
  • Presence of pacemaker or intracranial aneurysm clip
  • Serum creatinine >1.8 mg/dL OR GFR < 30mL/min
  • Pregnant or lactating female
Show all 10Show fewer
  • Inability to lie flat for >1 hour
  • Body Mass Index (BMI) >35
  • History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer.
  • Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: LCCC 1209: Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) for Staging of Muscle-Invasive Bladder Cancer

This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of [18F] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer.

Read the detailed description

This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of [18F] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer. All patients will undergo baseline FDG-PET-MRI and routine (standard of care) contrast enhanced abdominal/pelvic multi-detector computed tomography (MDCT). The imaging results will ultimately be compared to final pathology as the gold standard. If the accuracy of FDG-PET-MRI is improved as compared to standard MDCT, the investigators plan to conduct a larger follow-up study to confirm the results of this pilot study. In addition, this pilot study will set the stage for the evaluation of novel PET tracers in the imaging of bladder cancer.

Conditions
Bladder Cancer
Being tested
FDG PET/MR
Keywords
[18F], FDG Positron Emission Tomography-Magnetic Resonance Imaging, FDG-PET-MRI, Muscle-Invasive Bladder Cancer, Pilot Study, LCCC 1209, UNC Lineberger, MDCT
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • FDG PET/MRProcedure or surgery

    Also called Fluorodeoxyglucose Positron Emission Tomography MRI

    All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection

Study groups in NCT01655745
Study groupRoleWhat they receive
FDG PET/MR, No Chemotherapy ArmExperimentalPatients that are NOT receiving chemotherapy but are only completing surgical intervention.
Receives: Procedure: FDG PET/MR
FDG PET/MR, Chemotherapy ArmExperimentalPatients that are receiving chemotherapy prior to completing surgical intervention. These patients will receive a FDG PET/MR prior to chemotherapy and after completion of chemotherapy (at the time of pre-op, before surgical intervention).
Receives: Procedure: FDG PET/MR

What is being measured

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

  1. Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer

    The sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder will be evaluated by using the pathology from the radical cystectomy and lymph node dissection specimen or biopsy as the reference standard. The sensitivity and specificity of FDG-PET-MRI will be compared to conventional CT performed in all patients in this pilot study and FDG-PET-CT.

    Measured: 3 years

Secondary outcomes (1)

  1. Association of FDG-PET-MRI with RFS, DSS and OS in patients with muscle-invasive bladder cancer

    A positive FDG-PET-MRI or routine contrast enhanced abdominal/pelvic MDCT will be defined as evidence of metastatic disease as follows: 1) regionally, in the pelvic lymph nodes; or 2) distantly, to bone, lung, viscera or lymph nodes outside of the pelvis. OS will be defined as the time from the PET-MRI to the date of death from any cause. DSS will be defined from the date of PET-MRI to the date of death from disease. RFS will be defined as the time from the date of PET-MRI to recurrence or death from disease.

    Measured: 3 years

Timeline

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

  1. First posted2 Aug 2012 (estimated)
  2. Study start24 Jul 2012
  3. Primary completion1 Dec 2016
  4. Study completion1 Feb 2019

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 N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01655745
Sponsor's protocol ID
LCCC 1209
Status last verified
Oct 2019
First submitted
26 Jul 2012
Last updated
31 Oct 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing FDG PET/MR in people with Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 10 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 31 Oct 2019. 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.

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?

Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer (time frame: 3 years). 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 NCT01655745.

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 31 Oct 2019.

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