Testicular Germ Cell TumorNCT00045045
Positron Emission Tomography in Detecting Testicle Cancer
A study testing positron emission tomography and fludeoxyglucose F 18 in people with Testicular Germ Cell Tumor, run by Institute of Cancer Research, United Kingdom at 8 sites in United Kingdom.
Trial summary
RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Testicular Germ Cell Tumor
- What is being tested?
- positron emission tomography and fludeoxyglucose F 18
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 8 sitesUnited Kingdom
- Study dates
- May 2002to Jul 2007
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis with evidence of vascular (lymphatic or venous) invasion in primary specimen
- Clinical stage I on the basis of clinical examination, chest x-ray, and CT scan of the chest, abdomen, and pelvis
- Negative post-orchidectomy tumor markers (alpha-fetoprotein and beta human chorionic gonadotropin)
- High-risk disease
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No evidence of active inflammatory or infective diseases
- No other disease or prior malignancy that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- No more than 8 weeks since prior orchidectomy
Other
- No prior positron emission tomography scans
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Ipswich Hospital NHS Trust
Ipswich, England, IP4 5PD
Guy's and St. Thomas' Hospitals NHS Foundation Trust
London, England, SE1 9RT
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, WIT 3AA
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Royal South Hants Hospital
Southampton, England, 5O14OYG
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT
About this study
Official title: A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor
RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer.
PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of the testicle.
Read the detailed description
OBJECTIVES:
- Assess the ability of fludeoxyglucose F 18 positron emission tomography to predict relapse requiring adjuvant chemotherapy in patients with high-risk stage I non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis who are on current management protocols.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 1 hour later by positron emission tomography (PET) imaging. Patients with metastatic disease identified by FDG PET imaging may receive adjuvant chemotherapy according to the standard clinical practice at each participating center. Patients with no metastatic disease identified by FDG PET imaging are considered for entry into the MRC-TE08 trial (randomized trial of 2 CT scan frequencies in the surveillance of stage I teratoma) or are followed according to the standard surveillance schedule.
Patients with metastatic disease are followed every 6 months. Patients with no metastatic disease are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 4-6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 135 patients will be accrued for this study within 2-3 years.
- Conditions
- Testicular Germ Cell Tumor
- Being tested
- positron emission tomography, fludeoxyglucose F 18
- Keywords
- stage I malignant testicular germ cell tumor, testicular choriocarcinoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular teratoma, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor
- Medical subject headings
- Testicular Germ Cell Tumor, Testicular Neoplasms, Carcinoma, Embryonal, Seminoma, Teratoma, Endodermal Sinus Tumor, Teratoma, Testicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomographyProcedure or surgery
fludeoxyglucose F 18Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2002
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Investigators
- Robert A. Huddart, MD, Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045045
- Sponsor's protocol ID
- CDR0000256314
- Other IDs
- MRC-TE22, EU-20115
- Status last verified
- Sep 2002
- First submitted
- 6 Sep 2002
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
Huddart RA, O'Doherty MJ, Padhani A, Rustin GJ, Mead GM, Joffe JK, Vasey P, Harland SJ, Logue J, Daugaard G, Hain SF, Kirk SJ, MacKewn JE, Stenning SP; NCRI Testis Tumour Clinical Study Group. 18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group. J Clin Oncol. 2007 Jul 20;25(21):3090-5. doi: 10.1200/JCO.2006.09.3831.
PubMed 17634488
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor
- ClinicalTrials.gov ID
- NCT00045045
- Acronym / sponsor ID
- CDR0000256314
- Conditions
- Testicular Germ Cell Tumor
- Keywords
- stage I malignant testicular germ cell tumor, testicular choriocarcinoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- May 2002
- Study completion
- Jul 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer.
PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of the testicle.
Detailed description
OBJECTIVES:
- Assess the ability of fludeoxyglucose F 18 positron emission tomography to predict relapse requiring adjuvant chemotherapy in patients with high-risk stage I non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis who are on current management protocols.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 1 hour later by positron emission tomography (PET) imaging. Patients with metastatic disease identified by FDG PET imaging may receive adjuvant chemotherapy according to the standard clinical practice at each participating center. Patients with no metastatic disease identified by FDG PET imaging are considered for entry into the MRC-TE08 trial (randomized trial of 2 CT scan frequencies in the surveillance of stage I teratoma) or are followed according to the standard surveillance schedule.
Patients with metastatic disease are followed every 6 months. Patients with no metastatic disease are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 4-6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 135 patients will be accrued for this study within 2-3 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| positron emission tomography | Procedure or surgery | – |
| fludeoxyglucose F 18 | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Results publication: PubMed 17634488Huddart RA, O'Doherty MJ, Padhani A, Rustin GJ, Mead GM, Joffe JK, Vasey P, Harland SJ, Logue J, Daugaard G, Hain SF, Kirk SJ, MacKewn JE, Stenning SP; NCRI Testis Tumour Clinical Study Group. 18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group. J Clin Oncol. 2007 Jul 20;25(21):3090-5. doi: 10.1200/JCO.2006.09.3831.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A. Huddart, MD study chair
Royal Marsden NHS Foundation Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positron emission tomography and fludeoxyglucose F 18 in people with Testicular Germ Cell Tumor, run by Institute of Cancer Research, United Kingdom at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00045045, which also lists 1 linked publication.
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 Dec 2013.