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Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer

NCT01769950 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-01-17

No results posted yet for this study

Summary

Nodal involvement among patients with prostate cancer is known to be a poor prognostic factor. Traditionally, the presence or absence of nodal disease in patients with prostate cancer is ascertained with the use of anatomical imaging methods such as computed tomography (CT) and magnetic resonance imaging (MRI).

However, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather low, with reports placing the value to lie between 50-80%.

Positron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of prostate cancer disease burden in the primary, nodal and the metastatic areas.

The investigators in this prospective trial intend to utilize Choline-PET among all newly diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal disease on conventional imaging) and non-M1 (absence of metastatic disease on conventional imaging).

Conditions

Interventions

OTHER

Choline-PET

Carbon-11 or Fluorine-18 PET-CT will be acquired with a scanner with integrated PET and CT scanning ability at the time of diagnosis. It must be however noted that Choline-PET will not be considered as an alternative to magnetic resonance imaging (MRI). In fact, all patients will undergo MRI too.

Sponsors & Collaborators

  • Bangalore Institute of Oncology

    lead OTHER

Principal Investigators

  • Ajaikumar Basavalingaiah, MD · HealthCare Global- Bangalore Insititute of Oncology

  • Kumar G Kallur, MD · HealthCare Global- Bangalore Institute of Oncology

  • Swaroop Revannasiddaiah, MD · HealthCare Global- Bangalore Institute of Oncology

  • Sandeep Muzumder, MD · HealthCare Global- Bangalore Institute of Oncology

  • Govindarajan Mallarajapatna, MD · HealthCare Global- Bangalore Institute of Oncology

  • Raghunath S Krishnappa, MS, DNB · HealthCare Global- Bangalore Institute of Oncology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-01-31
Completion
2014-02-28

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769950 on ClinicalTrials.gov