Thyroid NeoplasmsPhase 2RIT in MTCNCT00467506
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
A Phase 2 study testing bispecific antibody and di-DTPA-131I in people with Thyroid Neoplasms, run by Nantes University Hospital at 11 sites in France.
Trial summary
Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- bispecific antibody and di-DTPA-131I
- How many people
- Not given
- Where
- 11 sitesFrance
- Study dates
- May 2004to Jan 2011
- 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
- 18 -75 years
- Karnofsky ≥ 70%
- Histological diagnosis of medullary thyroid carcinoma
- Calcitonin serum level Ê 100 pg/ml and Calcitonin or CEA doubling time £ 5 years
- Normal liver and renal functions
- Granulocytes ≥ 1500/mm3 and platelets ≥ 150 000/mm3
- No immunization
- Consent form signed
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre François Baclesse
Caen, 14076
CHU de Grenoble
Grenoble, 38043
hôpital du Cluzeau
Limoges, 87042
CHU
Lyon, 69394
Hôpital de la timone
Marseille, 13385
CHU
Nantes, 44093
CHU
Rouen, 76230
Centre René Huguenin
Saint-Cloud, 92210
Centre René Gauducheau
Saint-Herblain, 440805
Centre Paul Strauss
Strasbourg, 67065
Centre Claudius Régaud
Toulouse, 31052
About this study
Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)
- Conditions
- Thyroid Neoplasms
- Being tested
- bispecific antibody and di-DTPA-131I
- Keywords
- Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bispecific antibody and di-DTPA-131IDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startMay 2004
- Primary completionJan 2011
- Study completionJan 2011
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 Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Francoise Bodere, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467506
- Sponsor's protocol ID
- BRD/03/02-U
- Acronym
- RIT in MTC
- Status last verified
- Nov 2011
- First submitted
- 27 Apr 2007
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salaun PY, Campion L, Bournaud C, Faivre-Chauvet A, Vuillez JP, Taieb D, Ansquer C, Rousseau C, Borson-Chazot F, Bardet S, Oudoux A, Cariou B, Mirallie E, Chang CH, Sharkey RM, Goldenberg DM, Chatal JF, Barbet J, Kraeber-Bodere F. Phase II trial of anticarcinoembryonic antigen pretargeted radioimmunotherapy in progressive metastatic medullary thyroid carcinoma: biomarker response and survival improvement. J Nucl Med. 2012 Aug;53(8):1185-92. doi: 10.2967/jnumed.111.101865. Epub 2012 Jun 28.
PubMed 22743249
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT00467506
- Acronym / sponsor ID
- RIT in MTC / BRD/03/02-U
- Conditions
- Thyroid Neoplasms
- Keywords
- Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Apr 2007 (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.
Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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 (8 listed)
- 18 -75 years
- Karnofsky ≥ 70%
- Histological diagnosis of medullary thyroid carcinoma
- Calcitonin serum level Ê 100 pg/ml and Calcitonin or CEA doubling time £ 5 years
- Normal liver and renal functions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| bispecific antibody and di-DTPA-131I | Drug | – |
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 14 Sep 2026.
- Results publication: PubMed 22743249Salaun PY, Campion L, Bournaud C, Faivre-Chauvet A, Vuillez JP, Taieb D, Ansquer C, Rousseau C, Borson-Chazot F, Bardet S, Oudoux A, Cariou B, Mirallie E, Chang CH, Sharkey RM, Goldenberg DM, Chatal JF, Barbet J, Kraeber-Bodere F. Phase II trial of anticarcinoembryonic antigen pretargeted radioimmunotherapy in progressive metastatic medullary thyroid carcinoma: biomarker response and survival improvement. J Nucl Med. 2012 Aug;53(8):1185-92. doi: 10.2967/jnumed.111.101865. Epub 2012 Jun 28.
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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.
Francoise Bodere, MD principal investigator
Nantes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bispecific antibody and di-DTPA-131I in people with Thyroid Neoplasms, run by Nantes University Hospital at 11 sites 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 8 inclusion and 0 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
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 NCT00467506, 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 14 Sep 2026.