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Report for Clinical Trial NCT02088645

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas. In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning.

NCT02088645 Thyroid Cancer, Medullary
MeSH: Thyroid Neoplasms Thyroid Diseases
HPO: Abnormality of the thyroid gland Neoplasm of the thyroid gland Thyroid adenoma Thyroid carcinoma Thyroid follicular adenoma

1 Interventions

Name: 177Lu-PP-F11N

Type: Drug

Phase 0: One arm; Phase I: One arm


Primary Outcomes

Description: Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).

Measure: Phase 0: Scintigraphic visualisation rate

Time: up to 4 weeks

Description: Phase I study: Determination of the maximum tolerated dose (MTD)

Measure: Phase I: Maximum tolerated dose

Time: Up to 9 months

Secondary Outcomes

Description: Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.

Measure: Phase 0: Tumour-to-kidney radiation doses

Time: 8 and 16 weeks

Description: Calculation of tumour and organ radiation doses.

Measure: Phase 0: Radiation doses

Time: 8 and 16 weeks

Description: Evaluation of in vivo stability of 177Lu-PP-F11N.

Measure: Phase 0: In vivo stability

Time: 8 and 16 weeks

Description: Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.

Measure: Phase 0: Metabolites

Time: 8 and 16 weeks

Description: Evaluation of side reactions of 177Lu-PP-F11N.

Measure: Phase I: Side reactions

Time: 8, 16 and 24 weeks

Description: Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).

Measure: Phase 1: Biochemical response

Time: For the duration of 24 months.

Description: Evaluation of morphological therapy response (RECIST criteria).

Measure: Phase I: Morphological response

Time: 0, 3 and 12 months

Description: Determination of the tumour detection rate and correlation with surgery/histology, if possible.

Measure: Phase I: Tumour detection rate

Time: 8, 16 and 24 weeks

Description: Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).

Measure: Phase I: Organ radiation doses

Time: 8, 16 and 24 weeks

Description: Determination of overall survival of patients after therapy.

Measure: Phase 1: Overall survival

Time: Up to 5 years

Description: Evaluation of in vivo stability of 177Lu-PP-F11N.

Measure: Phase 1: In vivo stability

Time: 8, 16 und 24 weeks

Description: Measurement of the metabolites of 177Lu-PP-F11N.

Measure: Phase 1: Metabolites

Time: 8, 16 and 24 weeks

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 F11N

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.. 177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer. --- F11N ---

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.. 177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer. --- F11N --- --- F11N ---

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). --- F11N ---

177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. --- F11N ---

In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. --- F11N ---

Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).. Phase I: Maximum tolerated dose. --- F11N ---

Evaluation of in vivo stability of 177Lu-PP-F11N.. Phase 0: Metabolites. --- F11N ---

Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.. Phase I: Side reactions. --- F11N ---

Evaluation of side reactions of 177Lu-PP-F11N.. Phase 1: Biochemical response. --- F11N ---

Evaluation of in vivo stability of 177Lu-PP-F11N.. Phase 1: Metabolites. --- F11N ---

Measurement of the metabolites of 177Lu-PP-F11N.. Inclusion Criteria: Phase 0 study - Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy - Age > 18 years - Informed consent Phase I study - Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks - Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy- Age > 18 Years - Informed consent - Curative surgical therapy not possible Exclusion Criteria: Phase 0 study - Medication with Vandetanib 3 weeks before the study and during the study - Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface). --- F11N ---



HPO Nodes


HPO:
Abnormality of the thyroid gland
Genes 465
UBR1 PTEN CLPB TBC1D24 BIRC3 HNF1B TMEM67 BCOR OPA1 RAI1 TRNL1 MMP2 NNT LHX4 SLC16A2 POU2AF1 IQSEC2 TGIF1 GREM1 TREX1 CDON POU1F1 WDR11 DICER1 SALL1 PROKR2 RASGRP1 PAX8 DNAH1 NSDHL XRCC4 SDHD PRKCD LRP4 PTRH2 LEPR RET IYD PCSK1 KEAP1 DICER1 FOXI1 POLG PMM2 FGF8 MARS1 ENPP1 CDKN2C GPC1 TSHR DISP1 TSHR GLI3 FOXE1 FOXA2 TBX1 NKX2-1 EYA1 ALG8 HIRA CEP57 MLXIPL HSD17B3 CDH23 LEP CLIP2 TRNF MSTO1 LHX3 BUB1B FLCN PDE4D SEMA3C LIG4 PAX8 GLI2 TRAPPC9 MEN1 IFIH1 SRGAP1 CTLA4 DUOX2 KISS1R KCNJ18 PTEN TBL2 ALMS1 ROBO1 AIP MINPP1 DCAF17 BMPR1A FANCI SPIB PIK3C2A ARVCF MC2R MST1 SEC24C TG IL2RG SUFU HESX1 GNAS THRB KCNJ10 JMJD1C IL12RB1 MEN1 TRNS1 ND5 MMEL1 SEMA3D COMT TSHR TSHR SUFU LIFR SKI STAT3 APC TRNL2 TTC37 INSR GTF2I TDGF1 NRTN TXNRD2 TWNK FOXP1 TBX2 SMARCB1 TRNH PMS2 IDH1 PROP1 PRDM16 IYD LHX4 GNAS NNT TSHR PAX8 DLL1 SLC26A4 TRNL1 NKX2-1 GNAS SLC5A5 LRBA POLG TSHR GABRD GP1BB SIX3 POLR3A POU1F1 SKIV2L VPS13A KRAS NODAL GNAS XRCC4 MSH2 GATA6 IGSF1 CHD7 SEMA3E EDNRB TTC7A NRAS DDOST SLC26A4 DUOXA2 TRNS1 CACNA1S TSHB RAI1 CDKN1A RPS20 KCNJ18 SRD5A3 FOXP3 FBLN5 TRH TPO HPD GPR161 KAT6B FGFR1 COX1 THRB SAA1 STAR MRAP EDN3 NKX2-5 SCN4A FOXE1 CDC73 TG TRNW COX3 EFEMP2 RREB1 FOXE1 TSHR LHX4 NKX2-5 IL12A RNASEH2A DICER1 TGFBR2 NKX2-5 COX2 PAX8 MINPP1 FAS APC LIG4 DUOX2 POLR1D USP9X GLI3 RRM2B FMR1 PLAA C1S SASH1 BTNL2 SEC23B NLRP1 HRAS NKX2-1 NIN GABRA3 ADA TCOF1 FASLG ZFAT CDC73 CLCNKB PROP1 THRB RMRP APC SLC5A5 PRKAR1A FOXI1 RCBTB1 BCL10 BAZ1B APC LIG4 OTX2 WFS1 POU3F4 GAS1 HSD17B3 ND4 RFC2 RERE DACT1 MSH3 PIK3CA MMP14 THRA SLC26A4 ALX4 IDH2 FAN1 TWNK TRNQ TBX1 MSH3 GTF2IRD1 RAI1 CDKN2B PROP1 HESX1 TRNN C1QBP ARNT2 RET CDON CCBE1 CDH23 TNFSF15 RBM28 BRAF IFNG SOX3 SUGCT ITCH BMP4 PRKAR1A GPR35 STAT1 CTNS CASP10 CACNA1C LHX3 TRIP13 B3GLCT JAG1 KIAA0556 DEAF1 KDM6A TSC1 CTNNB1 PTEN FUCA1 ELN GLIS3 PLVAP FLCN KMT2D PTCH1 SIX1 BUB3 TSC1 RET LEPR PLCG2 SLC25A4 FUT8 EXOSC2 DNM1L PDGFB WFS1 POU1F1 ELN SRY MLH3 ND6 DUOXA2 SETBP1 STEAP3 FOXH1 TG DMXL2 HNF4A KAT6B UFD1 FMR1 EIF2AK3 PMS1 TNPO3 ECE1 CACNA1S TSC2 APOE AKT1 SGPL1 WDR4 RAG1 SDHC MLH1 MCM8 LMNA TF POLG2 EXT2 TSC2 NF2 BUB1 PIEZO1 FOXP3 PPP1R15B MSH6 RET APC HABP2 KCNJ10 FOXD3 LHX4 GLI2 CASR ZIC2 TRNW ARL6IP6 DCLRE1C FAS HESX1 TRNS2 IL7R STUB1 PRKAR1A POLR1C NPHS1 PIK3CA POMC ALMS1 FOXE1 LIMK1 TSHB RNASEH2B GNE STAT1 GDNF AIRE APC PDE4D SHH AKT1 TPO IL2RA HLA-DRB1 PROP1 FDX2 TRHR ACP5 SOX3 SLC12A3 HABP2 CDC73 DNAJC19 ND1 CDKN1B CHD7 IGH ADAR SLC26A4 MEN1 FOXE1 RNASEH2C TANGO2 EPCAM NKX2-1 TCF4 KLLN ADAMTSL1 SEC23B SEMA4A ZBTB20 PIK3CA GCH1 FLII RAG2 BMPR1A HBB USP9X ABCC6 SALL1 CTNS WRN PTEN MALT1 PTEN SDHB KCNAB2 MSTO1 DUOX2 CEP57 IRF5 CP TBX1 CDKN1B TSHR GATA1 TONSL SAMHD1 PHF21A ATRX DCLRE1C
Neoplasm of the thyroid gland
Genes 91
ECE1 CASP10 NRTN PTEN JAG1 AKT1 SDHC PTEN MLH1 HABP2 PMS2 APC CDC73 EDN3 LMNA FLCN CDKN1B SEMA3C CDC73 TG GREM1 SLC26A4 DICER1 MSH3 MSH6 RET GNAS APC HABP2 PIK3CA RASGRP1 KCNJ10 EPCAM RET KLLN SRGAP1 SDHD PRKCD SEC23B PTEN TGFBR2 SEMA4A PIK3CA FAN1 MINPP1 FAS RET MINPP1 APC MSH3 BMPR1A FAS KRAS CDKN2B KEAP1 DICER1 MSH2 FOXI1 BMPR1A EDNRB PRKAR1A NRAS MLH3 SEC23B WRN PTEN HRAS PTEN SLC26A4 CDKN2C RET PIK3CA NKX2-1 FOXE1 SDHB KCNJ10 FASLG MEN1 CDKN1A RPS20 CDC73 SEMA3D PRKAR1A FOXE1 CDKN1B GDNF PMS1 APC AKT1 APC FOXI1
Thyroid adenoma
Genes 19
CDKN1B FAS CASP10 CDC73 MSH3 FAS FASLG CDKN2B MEN1 CDKN1A AKT1 MSH3 PIK3CA RASGRP1 PRKAR1A PTEN CDKN1B PRKCD CDKN2C
Thyroid carcinoma
Genes 53
CASP10 JAG1 SDHC HABP2 APC CDC73 FLCN TG GREM1 SLC26A4 DICER1 APC HABP2 RASGRP1 KCNJ10 RET KLLN SRGAP1 SDHD PRKCD SEC23B PTEN PIK3CA MINPP1 FAS RET MINPP1 APC FAS KEAP1 DICER1 FOXI1 BMPR1A PRKAR1A NRAS SEC23B WRN PTEN HRAS SLC26A4 RET NKX2-1 FOXE1 SDHB KCNJ10 FASLG CDC73 PRKAR1A FOXE1 APC AKT1 APC FOXI1
Thyroid follicular adenoma