Medullary Thyroid CarcinomaPhase 1/2iTEP-CMTNCT01730638
ImmunoTEP for Patients With Medullary Thyroid Carcinoma.
A Phase 1/2 study testing • TF2 and 68 Ga-IMP-288 in people with Medullary Thyroid Carcinoma, run by Nantes University Hospital at 3 sites in France.
Trial summary
The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Carcinoma
- What is being tested?
- • TF2 and 68 Ga-IMP-288
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2013to Dec 2016
- Phase
- Phase 1/2
- 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
- Histological diagnosis of CMT
- Calcitonin> 150 pg / ml
- Complete treatment of the primary tumor
- at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable.
- Age ≥ 18 years
- Negative pregnancy test for women of childbearing age in the previous 2 days immuno-PET. Women of childbearing potential should use effective contraception take continuously for 3 months.
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- KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months
- Absence of serious illness or co-morbidity assessed risk
- Creatinine ≤ 2.5 normal
- Absence of cancer treatment within 6 weeks prior to the immuno-PET
- No history of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
- Lack of anti-antibodies in patients who have previously received antibodies and hypersensitivity to antibody or protein
- Informed consent signed
- Social Insurance
Who cannot join
- Pregnancy or breastfeeding
- Serious illness or co-morbidity assessed risk
- History of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
- Presence of anti-antibodies in patients who have previously received antibodies
- Known hypersensitivity to antibody or protein
- Need to establish a cancer treatment within 3 months of immuno-PET (before stock evaluation 3 months)
- Inability intellectual sign consent
- Patient protected by law
Trial locations and contacts
3 sites in 1 country.
France3 sites
Angers Hospital
Angers, 49100
Nantes Hospital
Nantes, 44100
Institut de Cancérologie de l'ouest, René Gauducheau
Saint-Herblain, 44805
About this study
Official title: Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.
The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion
Read the detailed description
Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.
A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor.
some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.
- Conditions
- Medullary Thyroid Carcinoma
- Being tested
- • TF2 and 68 Ga-IMP-288
- Keywords
- thyroid,, endocrine tumour, Nuclear medicine,, molecular imaging, ImmunoTEP
- Medical subject headings
- Carcinoma, Medullary, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• TF2 and 68 Ga-IMP-288Drug
Also called • TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG), • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68
| Study group | Role | What they receive |
|---|---|---|
| TF2 antibody/68Ga-IMP-288 | Experimental | TF2 coupled with 68 Ga-IMP-288 Receives: Drug: • TF2 and 68 Ga-IMP-288 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart.
A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.
Measured: one week
Secondary outcomes (1)
Sensibilité
Measured: 6 monts after immunoTEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary Thyroid CarcinomaStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francoise Bodere, PhD, MD, Principal investigator, Nantes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730638
- Sponsor's protocol ID
- PROG/10/94
- Acronym
- iTEP-CMT
- Status last verified
- May 2017
- First submitted
- 12 Nov 2012
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.
- ClinicalTrials.gov ID
- NCT01730638
- Acronym / sponsor ID
- iTEP-CMT / PROG/10/94
- Conditions
- Medullary Thyroid Carcinoma
- Keywords
- thyroid,, endocrine tumour, Nuclear medicine,, molecular imaging, ImmunoTEP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Gilead Sciences
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Nov 2012 (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 aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion
Detailed description
Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.
A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor.
some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TF2 antibody/68Ga-IMP-288 | Experimental | Drug: • TF2 and 68 Ga-IMP-288TF2 coupled with 68 Ga-IMP-288 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological diagnosis of CMT
- Calcitonin> 150 pg / ml
- Complete treatment of the primary tumor
- at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable.
- Age ≥ 18 years
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- Serious illness or co-morbidity assessed risk
- History of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
- Presence of anti-antibodies in patients who have previously received antibodies
- Known hypersensitivity to antibody or protein
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 |
|---|---|---|
| • TF2 and 68 Ga-IMP-288Also: • TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG), • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68 | Drug | TF2 antibody/68Ga-IMP-288 |
Primary outcome
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
Time frame: one week
Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart. A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.
1 secondary outcome
Sensibilité
Time frame: 6 monts after immunoTEP
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 26 Jul 2022.
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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, PhD, MD principal investigator
Nantes Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing • TF2 and 68 Ga-IMP-288 in people with Medullary Thyroid Carcinoma, run by Nantes University Hospital at 3 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 14 inclusion and 8 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288 (time frame: one week). 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 26 Jul 2022.