AzTrials
AzTrials

Renal Cell CarcinomaPhase 3NCT00606632

Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody

A Phase 3 study testing 124-Iodine-cG250 (124I-cG250) and CT in people with Renal Cell Carcinoma and Kidney Cancer, run by Heidelberg Pharma AG at 14 sites 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 multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma, Kidney Cancer
What is being tested?
124-Iodine-cG250 (124I-cG250) and CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
14 sitesUnited States
Study dates
Mar 2008to Dec 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subject is over 18 years of age.
  • Presence of a renal mass.
  • Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique).
  • Expected survival of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2.
  • The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1:
Show all 15Show fewer
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Serum bilirubin ≤ 2.0 mg/dL
  • Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Serum creatinine ≤ 2.0 mg/dL (calculated creatinine clearance >45 ml/min)
  • Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product. All females of childbearing potential must indicate intent to avoid pregnancy and must use an accepted, effective method of contraception for the duration of the study.
  • Recovered from toxicity of any prior therapy.
  • Able and willing to give valid written informed consent.

Who cannot join

  • Metastasis of primary tumor other than Renal Cell Carcinoma (RCC).
  • Prior history of malignancy within the last 5 years.
  • Prior exposure to murine proteins or chimeric antibodies.
  • Intercurrent medical condition that may limit the amount of antibody to be administered.
  • Intercurrent medical condition that renders the patient ineligible for surgery.
  • New York Heart Association Class III/IV cardiac disease.
Show all 16Show fewer
  • History of autoimmune hepatitis.
  • Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to 124I-cG250 infusion on day 1.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Lack of availability for immunological and clinical follow-up assessments.
  • Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrolment.
  • Women who are pregnant or breastfeeding.
  • Allergy to iodine, hyperthyroidism, or Grave's Disease.
  • Known allergic reaction to human serum albumin.
  • Contraindication for contrast-enhanced CT or PET/CT.
  • Contraindication to potassium iodide intake (see package insert).

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-0330

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • UNC School of Medicine-Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • Duke University Medical Center

    Durham, North Carolina, 27711

  • MD Anderson

    Houston, Texas, 77030-4009

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • David Geffen School of Medicine, UCLA

    Los Angeles, California, 90095-1721

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Stanford University Medical Center

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center & Research Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Comparative Study of PET/CT Versus Diagnostic CT for the Detection of Clear Cell Renal Cell Carcinoma in Pre-surgical Patients With Renal Masses Using Iodine-124 Labeled Chimeric G250 (124I-cG250)

This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.

Read the detailed description

A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and normal tissue have met with encouraging results. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.

Being tested
124-Iodine-cG250 (124I-cG250), CT
Keywords
Renal Mass, Clear Cell Renal Cell Carcinoma, Cancer of Kidney, Kidney Cancer, Neoplasms, cG250, antibody, monoclonal, Iodine 124, Positron-Emission Tomography, Kidney, Renal Cancer, Renal Neoplasms
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasms

What participants receive

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

  • 124-Iodine-cG250 (124I-cG250)Drug

    Also called Ca9-SCAN

    i.v. and PET/CT scan 4+/-2 days after administration

  • CTProcedure or surgery

    contrast enhanced CT scan

Study groups in NCT00606632
Study groupRoleWhat they receive
124-Iodine-cG250 (124I-cG250)OtherSingle arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.
Receives: Drug: 124-Iodine-cG250 (124I-cG250); Procedure: CT

What is being measured

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

  1. Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.

    Average estimate of three independent, blinded central readers per imaging modality on the proportion of participants that were correctly identified on the 124I-cG250 PET/CT Images of having (sensitivity) or not having (specificity) clear cell renal carcinoma (ccRCC) compared to CT images.

    Histopathology provided the standard-of-truth because it is the only definitive method for accurately identifying ccRCC.

    Measured: 6 months

Secondary outcomes (3)

  1. Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging

    The Accuracy is the proportion of participants with correct determinations of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.

    Measured: 6 months

  2. Positive Predictive Value (PPV)

    The Positive Predictive Value (PPV) reflects the Proportion of positive results that are true positive. The PPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.

    Measured: 6 months

  3. Negative Predictive Value (NPV)

    Negative Predictive Value (NPV) reflects the proportion of negative results that are true negatives. The NPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.

    Measured: 6 months

Timeline

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

  1. First posted4 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionNov 2009
  4. Study completionDec 2009

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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00606632
Sponsor's protocol ID
WX/20-001
Status last verified
Sep 2018
First submitted
21 Jan 2008
Last updated
2 Oct 2018
Data monitoring committee
No

Publications

  • Divgi CR, Pandit-Taskar N, Jungbluth AA, Reuter VE, Gonen M, Ruan S, Pierre C, Nagel A, Pryma DA, Humm J, Larson SM, Old LJ, Russo P. Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 (124I-cG250) and PET in patients with renal masses: a phase I trial. Lancet Oncol. 2007 Apr;8(4):304-10. doi: 10.1016/S1470-2045(07)70044-X.

    PubMed 17395103

  • Divgi CR, Uzzo RG, Gatsonis C, Bartz R, Treutner S, Yu JQ, Chen D, Carrasquillo JA, Larson S, Bevan P, Russo P. Positron emission tomography/computed tomography identification of clear cell renal cell carcinoma: results from the REDECT trial. J Clin Oncol. 2013 Jan 10;31(2):187-94. doi: 10.1200/JCO.2011.41.2445. Epub 2012 Dec 3.

    PubMed 23213092

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 124-Iodine-cG250 (124I-cG250) and CT in people with Renal Cell Carcinoma and Kidney Cancer, run by Heidelberg Pharma AG at 14 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 15 inclusion and 16 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 124I-cG250 PET/CT Versus Diagnostic CT. (time frame: 6 months). 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 NCT00606632, which also lists 2 linked publications.

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 2 Oct 2018.

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