The study aims to determine the value of combined 124I PET and FDG PET to avoid futile treatment with 131I. Secundary aims are to validate functional imaging with histopathological correlation, and to optimize and standardize the new 124I technique…
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The number of futile 131I treatments that can be avoided using this imaging
strategy.
Secondary outcome
- Synchronised introduction and QA/QC of 124I-PET in the Netherlands
- Translational correlation of 124I-PET and FDG-PET with histopathology (where
available) and treatment outcome, in an explorative setting.
- To investigate whether 124I-PET has the same diagnostic, dosimetric and
prognostic yield during stimulation with rhTSH and hormone withdrawal combined
with low-idodine diet.
Background summary
The follow-up of differentiated thyroid carcinoma (DTC) primarily consists of
thyroglobulin (Tg) measurements in serum during stimulation with recombinant
human TSH (rhTSH). However, when recurrence is suspected, this strategy does
not provide tumor localization or restaging. In case of elevated Tg the
standard approach is blind treatment with a high dose radioactive 131Iodine,
after which the disease may be localised in many cases using posttreatment
scintigraphy. This strategy is not effective for all patients: a negative
posttreatment scan and insufficient response to treatment is seen in about 40%
of cases. In these patients the treatment was futile, but did induce radiation
exposure, costs, and potentially side-effects.
Recent investigations with 124Iodine PET has shown a high sensitivity for
iodine-avid DTC and a high predictive value for ineffective 131I treatment. A
negative 124I PET could prevent futile treatment, while a positive scan can be
used to restage and optimize treatment. On the other hand, investigations with
FDG PET have shown a high sensitivity for iodine-negative DTC. A negative FDG
PET predicts a good prognosis, while a positive scan predicts poor prognosis
and response to 131I treatment and at the same time restages for alternative
treatments (resection, RT, systemic). Therefore, it is likely that combined
124I PET and FDG PET prior to blind 131I treatment will be able to influence
treatment decisions.
Study objective
The study aims to determine the value of combined 124I PET and FDG PET to avoid
futile treatment with 131I. Secundary aims are to validate functional imaging
with histopathological correlation, and to optimize and standardize the new
124I technique during its introduction in the Netherlands.
Study design
Included patients will receive an additional combination of Iodine-124 PET/CT
and FDG PET/CT prior to blind treatment with radioactive iodine. Determined
tumor characteristics will be correlated with treatment outcome, to define
selection criteria that will predict the treatment outcome. In selected
centers, patients will also receive additional scans during treatment to
evaluate optimiziation of the treatment, and / or additional scans after 6
months to determine the lesion-based response correlated with tumor
characteristics.
Study burden and risks
Additional scans with a limited radiation exposure prior to treatment, and in
selected cases also during and / or after treatment. There are no known or
expected side effects.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
1. Patients with a history of differentiated thyroid cancer
2. After complete thyroidectomy and ablation of functional remnants with 131I.
3. Planned for blind high dose 131I treatment based on biochemically suspected recurrence, defined as a Tg-level above 2.0 ng/ml.
4. Ultrasonography of the neck performed < 2 months prior to inclusion.
Exclusion criteria
1. Age < 18 years
2. Pregnancy
3. Incapacitated subjects
4. Contrast enhanced CT performed < 4 months prior to inclusion
5. I-131 therapy performed < 12 months prior to inclusion
6. Indication for other therapy modality (ie. surgery in case of a positive ultrasonography, radiotherapy, embolization or chemotherapy)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL37266.031.11 |
| OMON | NL-OMON27626 |