AzTrials
AzTrials

Hepatocellular CarcinomaPhase 2CHOLPETNCT01377220

Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma

A Phase 2 study testing 11C-Choline in people with Hepatocellular Carcinoma, run by Commissariat A L'energie Atomique at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver. Recently, several research studies reported that 11C-choline PET has shown a high detection rate of well differentiated HCC, which is an early stage of primary liver cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
11C-Choline
Type of treatment
Injection or infusion
How many people
30 participants
Where
1 siteFrance
Study dates
Jun 2011to Jun 2014
Phase
Phase 2
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

  • Patients up to 18 years old with
  • Patients with suspicion hepatocellular carcinoma on conventional imaging(hepatic ultrasonography, abdominal computed tomography, dynamic resonance magnetic)and/or on alpha fetoprotein measurement
  • Patients with suspicion recurrence of hepatocellular carcinoma on conventional imaging(hepatic ultrasonography, abdominal computed tomography, dynamic resonance magnetic)and/or on alpha fetoprotein measurement
  • Patients which perform two conventional imaging techniques, consisting in dynamic magnetic resonance imaging (MRI) and computed tomography (CT)and must have an alpha fetoprotein measurement
  • Patients which perform 18F-FDG PET-CT
  • Informed Consent Form signed and dated by patients
  • Patients which are "Security Social" affiliated

Who cannot join

  • Pregnant or suckling women
  • Women able to procreate, without efficient birth control
  • Patients with an other tumoral disease
  • Patients with chemotherapy or surgery from less than four weeks
  • Patients with radiotherapy from less four months

Trial locations and contacts

1 site in 1 country.

Maria-Angéla M-A CASTILLA-LIEVRE, MD contact

01-45-37-48-39

angele.castilla@abc.aphp.fr

France1 site

  • CEA-SHFJ

    Orsay, 91400

    Maria-Angéla M-A CASTILLA-LIEVRE, MD, 01-45-37-48-39, angele.castilla@abc.aphp.fr

Other trials in France

About this study

Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver.

Recently, several research studies reported that 11C-choline PET has shown a high detection rate of well differentiated HCC, which is an early stage of primary liver cancer. The aim of this study was to prospectively evaluate the diagnostic accuracy of 11C-choline PET-CT to detect HCC in cirrhotic or non cirrhotic patients.

Read the detailed description

Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver. Although the histological examination remains the reference for the diagnosis, it may be difficult to obtain biopsy material because of difficulty in getting to the lesion or due to their small size. However, it is know that the size of the lesion remains a major prognostic factor, implying the need for an earliest detection, which enhances the chance for curative treatment.PET enables the study of changes in the glucidic or lipidic metabolism of cancer cells. PET-CT, providing both metabolic and anatomic information, improves the performances of this technique. PET with 18F-FDG has not been sensitive enough in the detection of HCC, except in cases of low grade. Recently, several research studies reported that 11C-choline PET has shown a high detection rate of well differentiated HCC, which is an early stage of primary liver cancer.

The study include 30 patients presenting a suspicion of HCC with or without cirrhosis. Each patient will be examined with two conventional imaging techniques, consisting in dynamic magnetic resonance imaging and computed tomography; alpha fetoprotein measurement will be taken. PET-CT will be acquired after an intravenous injection of 11C-choline. The 11C-choline PET-CT performance for HCC diagnosis will be compare to histological analysis obtained by a tumoral liver biopsy, or by using of the American Association for the study of Liver Disease diagnostic criteria. In absence of the two criteria , the follow up within one year will serve as a reference.

Being tested
11C-Choline
Keywords
Hepatocellular carcinoma, Positron Emission Tomography/computed tomography (PET-CT), 11C-Choline, alpha fetoprotein, Dynamic magnetic resonance imaging, Abdomen computed tomography, Tumoral liver biopsy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • 11C-CholineDrug

    11C-Choline : 6MBq/kg on direct intravenous on one minute.

Timeline

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

  1. First posted21 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2013 (estimated)
  4. Study completionJun 2014 (estimated)

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 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01377220
Sponsor's protocol ID
2010-020221
Acronym
CHOLPET
Status last verified
Jan 2011
First submitted
7 Jun 2011
Last updated
21 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • Talbot JN, Fartoux L, Balogova S, Nataf V, Kerrou K, Gutman F, Huchet V, Ancel D, Grange JD, Rosmorduc O. Detection of hepatocellular carcinoma with PET/CT: a prospective comparison of 18F-fluorocholine and 18F-FDG in patients with cirrhosis or chronic liver disease. J Nucl Med. 2010 Nov;51(11):1699-706. doi: 10.2967/jnumed.110.075507. Epub 2010 Oct 18.

    PubMed 20956466

  • Tolvanen T, Yli-Kerttula T, Ujula T, Autio A, Lehikoinen P, Minn H, Roivainen A. Biodistribution and radiation dosimetry of [(11)C]choline: a comparison between rat and human data. Eur J Nucl Med Mol Imaging. 2010 May;37(5):874-83. doi: 10.1007/s00259-009-1346-z. Epub 2010 Jan 13.

    PubMed 20069295

  • Park JW, Kim JH, Kim SK, Kang KW, Park KW, Choi JI, Lee WJ, Kim CM, Nam BH. A prospective evaluation of 18F-FDG and 11C-acetate PET/CT for detection of primary and metastatic hepatocellular carcinoma. J Nucl Med. 2008 Dec;49(12):1912-21. doi: 10.2967/jnumed.108.055087. Epub 2008 Nov 7.

    PubMed 18997056

  • Ho CL, Yu SC, Yeung DW. 11C-acetate PET imaging in hepatocellular carcinoma and other liver masses. J Nucl Med. 2003 Feb;44(2):213-21.

    PubMed 12571212

  • Hwang KH, Choi DJ, Lee SY, Lee MK, Choe W. Evaluation of patients with hepatocellular carcinomas using [(11)C]acetate and [(18)F]FDG PET/CT: A preliminary study. Appl Radiat Isot. 2009 Jul-Aug;67(7-8):1195-8. doi: 10.1016/j.apradiso.2009.02.011. Epub 2009 Feb 20.

    PubMed 19342249

  • Talbot JN, Gutman F, Fartoux L, Grange JD, Ganne N, Kerrou K, Grahek D, Montravers F, Poupon R, Rosmorduc O. PET/CT in patients with hepatocellular carcinoma using [(18)F]fluorocholine: preliminary comparison with [(18)F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2006 Nov;33(11):1285-9. doi: 10.1007/s00259-006-0164-9. Epub 2006 Jun 27.

    PubMed 16802155

  • Yamamoto Y, Nishiyama Y, Kameyama R, Okano K, Kashiwagi H, Deguchi A, Kaji M, Ohkawa M. Detection of hepatocellular carcinoma using 11C-choline PET: comparison with 18F-FDG PET. J Nucl Med. 2008 Aug;49(8):1245-8. doi: 10.2967/jnumed.108.052639. Epub 2008 Jul 16.

    PubMed 18632827

  • Salem N, Kuang Y, Wang F, Maclennan GT, Lee Z. PET imaging of hepatocellular carcinoma with 2-deoxy-2[18F]fluoro-D-glucose, 6-deoxy-6[18F] fluoro-D-glucose, [1-11C]-acetate and [N-methyl-11C]-choline. Q J Nucl Med Mol Imaging. 2009 Apr;53(2):144-56. Epub 2008 Nov 28.

    PubMed 19039303

  • Hara T, Kosaka N, Shinoura N, Kondo T. PET imaging of brain tumor with [methyl-11C]choline. J Nucl Med. 1997 Jun;38(6):842-7.

    PubMed 9189127

  • Hara T, Kosaka N, Kishi H. PET imaging of prostate cancer using carbon-11-choline. J Nucl Med. 1998 Jun;39(6):990-5.

    PubMed 9627331

  • Li CW, Kuo YC, Chen CY, Kuo YT, Chiu YY, She FO, Liu GC. Quantification of choline compounds in human hepatic tumors by proton MR spectroscopy at 3 T. Magn Reson Med. 2005 Apr;53(4):770-6. doi: 10.1002/mrm.20412.

    PubMed 15799049

  • Kojiro M, Roskams T. Early hepatocellular carcinoma and dysplastic nodules. Semin Liver Dis. 2005;25(2):133-42. doi: 10.1055/s-2005-871193.

    PubMed 15918142

  • Kim HO, Kim JS, Shin YM, Ryu JS, Lee YS, Lee SG. Evaluation of metabolic characteristics and viability of lipiodolized hepatocellular carcinomas using 18F-FDG PET/CT. J Nucl Med. 2010 Dec;51(12):1849-56. doi: 10.2967/jnumed.110.079244.

    PubMed 21098794

  • Kim YK, Lee KW, Cho SY, Han SS, Kim SH, Kim SK, Park SJ. Usefulness 18F-FDG positron emission tomography/computed tomography for detecting recurrence of hepatocellular carcinoma in posttransplant patients. Liver Transpl. 2010 Jun;16(6):767-72. doi: 10.1002/lt.22069.

    PubMed 20517911

  • Wolfort RM, Papillion PW, Turnage RH, Lillien DL, Ramaswamy MR, Zibari GB. Role of FDG-PET in the evaluation and staging of hepatocellular carcinoma with comparison of tumor size, AFP level, and histologic grade. Int Surg. 2010 Jan-Mar;95(1):67-75.

    PubMed 20480845

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 11C-Choline in people with Hepatocellular Carcinoma, run by Commissariat A L'energie Atomique at 1 site in France.

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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Jun 2011. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria-Angéla M-A CASTILLA-LIEVRE, MD (01-45-37-48-39, angele.castilla@abc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01377220, which also lists 20 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 21 Jun 2011.

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