Thyroid CarcinomaNCT00749697
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases
A study testing SPECT scan in people with Thyroid Carcinoma and Metastatic Sites Lung Bone Nodal, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The main purpose of the study is to establish a relationship between the administered activity of the radioiodine and absorbed dose in the tumor sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Carcinoma, Metastatic Sites Lung Bone Nodal
- What is being tested?
- SPECT scan
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to Jul 2010
- 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
- age above 18
- histological confirmation of the differentiated thyroid carcinoma available
- WHO performance score 0-2
- metastatic sites lung and/or bone and/or nodal (radiologically measurable disease > 1 cm)
- life expectancy > 6 months
- patient has undergone total/near total thyroidectomy
- no past history of sensitivity/reaction to 1311
Who cannot join
- non iodine concentrating tumours
- received chemotherapy or radiotherapy in 6 weeks
- pregnant or breast feeding patients
- iodine contrast injection in last 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
London, Sutton, SM2 5PT
Dr Kate Newbold, 0208661 3638, kate.newbold@rmh.nhs.uk
Dr Prasad Dandekar, 020 86613454, prasad.dandekar@rmh.nhs.uk
About this study
Official title: Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine
The main purpose of the study is to establish a relationship between the administered activity of the radioiodine and absorbed dose in the tumor sites.
Read the detailed description
Study Design - the assessment of patients with multiple tumour sites with metastatic thyroid cancer to correlate the administered activity to absorbed dose. Patients will receive the standard therapy dose of 5.5 GBq as per the hospital policy and there will be no change for the protocol purpose.
- Being tested
- SPECT scan
- Keywords
- radioiodine, differentiated thyroid cancers, dosimetry, metastases
- Medical subject headings
- Thyroid Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT scanOther
SPECT scan measures the amount of radio activity that is remaining in patients' body after the consumption of radio iodine for therapeutic purpose
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan
Secondary outcomes (1)
The secondary outcomes will be to assess the response at 6 months post therapy in each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Dr Kate Newbold, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749697
- Sponsor's protocol ID
- CCR3047
- Status last verified
- Sep 2008
- First submitted
- 5 Sep 2008
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine
- ClinicalTrials.gov ID
- NCT00749697
- Acronym / sponsor ID
- CCR3047
- Keywords
- radioiodine, differentiated thyroid cancers, dosimetry, metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 9 Sep 2008 (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.
The main purpose of the study is to establish a relationship between the administered activity of the radioiodine and absorbed dose in the tumor sites.
Detailed description
Study Design - the assessment of patients with multiple tumour sites with metastatic thyroid cancer to correlate the administered activity to absorbed dose. Patients will receive the standard therapy dose of 5.5 GBq as per the hospital policy and there will be no change for the protocol purpose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age above 18
- histological confirmation of the differentiated thyroid carcinoma available
- WHO performance score 0-2
- metastatic sites lung and/or bone and/or nodal (radiologically measurable disease > 1 cm)
- life expectancy > 6 months
Key exclusion criteria (4 listed)
- non iodine concentrating tumours
- received chemotherapy or radiotherapy in 6 weeks
- pregnant or breast feeding patients
- iodine contrast injection in last 3 months
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 |
|---|---|---|
| SPECT scanSPECT scan measures the amount of radio activity that is remaining in patients' body after the consumption of radio iodine for therapeutic purpose | Other | – |
Primary outcome
The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan
1 secondary outcome
The secondary outcomes will be to assess the response at 6 months post therapy in each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2008.
Related trials for Thyroid Carcinoma
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
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.
Dr Kate Newbold principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECT scan in people with Thyroid Carcinoma and Metastatic Sites Lung Bone Nodal, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 4 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 9 Sep 2008. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Kate Newbold (020 86613638, kate.newbold@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2008.